Not So Different: A Podcast from The Center for Biosimilars

On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.

On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.

On this episode of Not So Different, the end of the second quarter brings with it expense reports, new biosimilar business deals, and insights into how federal policy impacts biosimilar company pursuits.

On this episode of Not So Different, we review all the big biosimilar policy news from July, including discussions regarding biosimilar policies, in both the US and abroad, as well as 3 highly anticipated FDA approvals.

Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.

On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.

In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.

On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars and the feasibility of switching to them.

In April, The Center for Biosimilars had the pleasure of attending Festival of Biologics USA in San Diego, California, where we got to cover major presentations and discuss the global biosimilar industry with valued experts in the space. One of those experts is joining us today to discuss takeaways from the meeting: Dracey Poore, director of biosimilars at Cardinal Health, who presented on market insights that came out of Cardinal Health's annual biosimilar report. Prior to her work with Cardinal Health, Dracey worked for Organon and Merck as associate director of US oncology biosimilar marketing strategy. The Cardinal Health biosimilar report is a hotly anticipated report for the industry, presenting on how the market is developing as well as evolving prescriber trends and perspectives on these medications. We are pleased to have Dracey for her first guest appearance on Not So Different!

On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.

On this episode of Not So Different, The Center for Biosimilars® discusses all the conference coverage, adalimumab data, and market insights to come out of the biosimilar dermatology space in March 2024.

On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.

On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.

On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum returns, to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.

On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.

On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will change the space going forward.

On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).

On this episode, we discuss the abundance of oncology news from November, especially during Global Biosimilars Week 2023, which was themed around the growth of oncology biosimilars.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, examines the evolution of the oncology biosimilar space in this special episode of Not So Different to close out Global Biosimilars Week 2023.

On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.

On this episode, we will discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.

On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.

On this episode, we’re going to be giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.

On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, expanded on ways to make biosimilar development faster and cheaper without compromising on safety and efficacy and how these practices can ensure a sustainable market for the future.

On this episode, we’re going to be giving a rundown some of the biggest stories in the immunology space regarding biosimilars, like the launch of 7 adalimumab biosimilars, the release of multiple market trend reports, and clinical trial results on traditionally bypassed disease states.

Laura Wingate, from the Crohn's & Colitis Foundation, explains some of the challenges regarding educating patients and providers on biosimilars for inflammatory bowel disease (IBD) as well as whether the gastroenterology space is ready for the influx of adalimumab biosimilars.

On this episode, we’re going to be recapping some of the biggest stories in the business space regarding biosimilars, including adalimumab preparation, partnerships for commercialization, and more.

On this episode, we’re going to be recapping some of the biggest stories in the immunology space regarding biosimilars, including a new European approval, ustekinumab biosimilar delays, and more.

At Asembia 2023 in Las Vagas, Nevada, Tasmina Hydery, associate director of Digital Solutions at AmerisourceBergen, presented on the future of the biosimilars industry as well as how payers have responded to the influx of new biosimilar products in the United States. During the session, she shared results from AmerisourceBergen's report on the biosimilars pipeline, sharing survey results on how payers place biosimilars on formularies, their views on interchangeability, and their use of prior authorization and step therapy strategies to encourage providers to prescribe preferred products. On today's episode, we spoke with Tasmina and her colleague, as well as a returning guest on the Not So Different podcast, Brian Biehn, senior director of Biosimilar Commercialization at AmerisourceBergen, about some of the points brought up during the presentation and some of the pricing trends that we're seeing in the space.

In light of 2 blockbuster originators, namely Humira (adalimumab) and Stelara (ustekinumab), losing market exclusivity in 2023, 3 doctors penned supplement in The American Journal of Managed Care®. On this episode, Vibeke Strand, MD, one of the co-authors, explored how health systems can take charge and boost biosimilar adoption.

On this episode of Not So Different, we recap some of the main news in April regarding biosimilars used to treat rheumatic conditions, including some progressions and some setbacks as well as research on nonmedical switching from originators to biosimilars.

What can practices do to prepare for all the biosimilars to treat rheumatoid arthritis (RA) coming down the pipeline? And how can they ensure that the lower-than-anticipated adoption rates for infliximab biosimilars are not repeated? Robert Zutaut, RPh, from McKesson Provider Solutions, tackles all this and more on this episode of Not So Different.

On this episode, we’ll discuss some of the global biosimilar policy news that came out during the month of March, including a new bill in Congress and 2 Canadian jurisdictions implementing switching policies.

Although the oncology space is well-known for having the most successful biosimilar uptake, there are barriers that remain. Community oncologists and patients still have to reckon with pharmacy benefit manager (PBM) and payer formulary decisions, incentives for prescribing reference products, and inflated drug prices. However, community oncology practices have a unique opportunity to help boost biosimilar adoption and create savings for patients. Today, I’m joined by Mark Guyot, senior director of unity provider engagement at McKesson, to discuss some best practices for biosimilar implementation in community oncology practices. Mark worked on creating and conducting McKesson’s real-world analysis that identified challenges and provided necessary support and education for successful biosimilar adoption. The analysis also led to changes within community oncology practices, resulting in significantly decreased care costs for patients, as well as annual cost savings to Medicare, totaling

On this episode of Not So Different, we chronicled the latest gastroenterology news from February, including several updates on adalimumab and infliximab biosimilars and industry analyses on the utilization of these drugs and patient confidence in gastroenterologists’ recommendations.

Recently, Vizient, a member-owned health care consulting company, published the Winter 2023 edition of its Pharmacy Market Outlook Report. The report commented onthe current trends of the biosimilars market, including the impact that inflation and the COVID-19 pandemic are having on biosimilar utilization and drug prices as a whole. It also discussed the hotly-anticipated US launches of upwards of 8 biosimilars referencing Humira (adalimumab) that are expected throughout 2023 and how issues surrounding payer preferences and white bagging policies could influence the uptake of these products. On this episode of Not So Differet, we spoke with Carina Dolan, PharmD, MS, BCOP, senior director for clinical oncology and pharmaceutical outcomes at Vizient. Prior to her role with Vizient, she served as a hematology and oncology clinical pharmacist at Baylor University Medical Center. In the past, she’s written for The American Journal of Managed Care®, the written journal associated with our

On this episode of Not So Different, we reminisced about the major biosimilar news to come out of the rheumatology field during January 2023, including the launch of the first Humira (adalimumab) biosimilar.

On this episode of Not So Different, the FDA’s Sarah Yim, MD, discusses how the FDA is working improve public trust in ophthalmology biosimilars and interchangeable products as part of a 3-part multimedia interview series.

To say goodbye to 2022 and welcome in the new year, The Center for Biosimilars recaps the biggest news stories and milestones from the past 12 months as well as list of the top 5 podcast episodes of the year.

On this episode, Brian Biehn, senior director of biosimilar commercialization at AmerisourceBergen, explored how the new year may play out for biosimilars, including his predictions or how uptake will be influenced in the adalimumab market and how government policies will impact the competitiveness of the market.

On this episode of Not So Different, we recap some of the big regulatory news to come out of November, including some progress for insulin biosimilars, the European approval of another ranibizumab biosimilar, and the congressional introduction of a US Senate bill that is seeking to nix switching study requirements for interchangeability.

Chad Pettit, the executive director of marketing and global biosimilars commercial lead at Amgen, discusses the most recent version of Amgen's Biosimilar Trends Report and what the report says about the current biosimilar market and how it could develop in the years to come.

Craig Burton, senior vice president of policy and strategic alliances at the Association for Accessible Medicines and executive director of the Biosimilars Council, gives insight into the many health policies that the Biden Administration has implemented in 2022 as well as their possible impact on biosimilar adoption.

On this episode of Not So Different, we recap some of the biosimilar policy news from the around the world during October, including the implementation of a biosimilars switching policy, the European Union declaration of biosimilars as interchangeable, and the reauthorization of the Biosimilars User Fee Act.

On this week’s episode, we’re discussing the stresses that practices and clinics face when trying to manage biosimilars as well as some policy considerations that administrators should keep in mind as more biosimilars enter the market and more payers add them to formularies. I am joined by Kathy Oubre, MS, chief executive officer of Pontchartrain Cancer Center, and a member of The Center for Biosimilars® Advisory Board. She is an expert on the administration and practice perspective of managing biosimilars and has extensive experience supervising a practice that has had to adapt to the growing body of oncology biosimilars that have launched on the US market.

This episode is going to take a look at some of the big stories regarding oncology biosimilars throughout the month of September, including 2 FDA approvals, and the withdrawal of a European application.

Starting in January next year, the United States will welcome up to 10 adalimumab biosimilars referencing Humira, one of the most profitable drug in the world. Currently, there are several barriers to uptake to biosimilars, including payer and pharmacy benefit manager interference with formulary placement, misaligned incentives that favor prescribing the reference product over biosimilars, and reference manufacturer-led anti-competitive practices preventing biosimilar market entry. However, there are a number of policy and procedural efforts being put in place by congressional leaders, the FDA, and HHS the could help to boost biosimilar uptake and give adalimumab biosimilars a real chance to gain market share. Today, I’m joined by Julie Reed, executive director of the Biosimilars Forum, a nonprofit organization aimed at the advancement of biosimilar adoption through collaboration with biosimilar manufacturers. Prior to her work with the Forum, she served as vice president and global

This summer, Vizient, a member-owned health care consulting company, published its Pharmacy Market Outlook report for 2022. The report provided insight into the current status of the US biosimilar market place and broke down some of the key aspects stakeholders should keep an eye on as the United States enters a new phase of biosimilar competition. On this episode, The Center for Biosimilars® welcomes Steven Lucio, PharmD, BCPS, senior principal of pharmacy solutions at Vizient. Dr. Lucio has been working with Vizient on its Pharmacy Market Outlook report, which makes several predictions for how the biosimilar market is expected to develop in the near future, including how the first year of adalimumab. This episode is part of a larger series called “WHEN CHOICES ARRIVE: Competition & Consequences,” consisting of 4 articles and 2 podcasts. The series delves into everything that stakeholders need to know as everyone prepares for the 2023 introduction of adalimumab biosimilars.

On this episode of Not So Different, we look back at some of the biggest regulatory events to happen in the biosimilar space during August, including 2 European approvals, 2 US approvals, and the advancement of the Inflation Reduction Act of 2022.

On this week’s episode, we’re taking a look at a new health technology tool that could help improve biosimilar utilization and patient care within infusion centers. Many infusion medications are biologic drugs and juggling multiple biosimilars for the same reference product can place undue burden on infusion centers and result in medication errors, such as accidentally administering a product not covered by a patient’s insurance. McKesson’s Intrafusion service enables better efficiency within infusion centers and relieves some of the pressure providers and administrators face when trying to manage infusion facilities, including managing biosimilar administration. Today, I’m joined by Cheryl Vaughn, vice president of clinical services at McKesson. She has worked closely with McKesson’s Intrafusion team to help develop the tool and has been with the company for over 5 years. She also has over 8 years of experience working as a registered nurse prior to her time at McKesson.

On this episode of Not So Different, we recapped some of the biggest biosimilars news that happened over the past month, including updates on clinical trials for oncology biosimilars as well as a survey on whether patients were given adequate information prior to switching a biosimilar.

On this podcast episode, The Center for Biosimilars spoke with Chronic Manolis from UPMC Health Plan to discuss how health care policies may shift as adalimumab biosimilars referencing Humira come to market in 2023, including how providers and payers can ensure equitable access.

On this episode of Not So Different, we spoke with Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars at Cardinal Health, to discuss the US launch of Byooviz, the first ophthalmology biosimilar and the first biosimilar referencing Lucentis (ranbizumab) in the United States. We also talked about how this launch is expected to impact ophthalmology care going forward and what needs to be done to ensure patients have adequate access to this biosimilar and other ophthalmology biosimilars in the future.

In the United States, biosimilars can cause some concerns for patients and physicians who may not be fully versed in what biosimilars are. Because biosimilars are not the same as generic drugs, differ slightly from their originator products, and are often used in complex disease states like rheumatology, oncology, and ophthalmology, providers and patients may have the impression that biosimilars are less effective and safe than originators. Education is often seen as a pivotal tool in building confidence in biosimilars, as it can dispel myths and provide real-world information on the history and use of these products. We sat down with Kirollos Hanna, PharmD, the manager of Oncology Pharmacy at the University of Minnesota Medical Center, to discuss how he has worked to build patient and physician confidence in biosimilars and what strategies worked best for his practice. Hanna is also an associate editor for the Journal of the Advanced Practitioner in Oncology and an assistant professo

In the United States, biosimilar uptake has been slow, largely owing to 2 major concerns: that discounts for biosimilars are not substantial enough yet to contribute to significant savings and that physicians and patients are not fully convinced that biosimilars are as safe and effective as their reference product counterparts. Although there have been plenty of clinical studies and analyses to support the savings potential and comparative safety and efficacy of biosimilars, many are still looking for real world evidence. We sat down with Kirollos Hanna, PharmD, the manager of Oncology Pharmacy at the University of Minnesota Medical Center, an associate editor for the Journal of the Advanced Practitioner in Oncology, and an assistant professor at the Mayo Clinic School of Medicine, to discuss his real world experience incorporating biosimilars into his practice and how he addresses concerns about biosimilars.

Although the European Union has been in the biosimilars game longer than the United States, both are considered leaders in biosimilar use. Generics were the first copycat drugs, however, there are lessons to be learned from this experience. But biologics, which are made from living organisms, are not as simple to copy as generics are. There will be minute differences between biosimilars and originator biologics, and there will even be small differences between different batches of the same originator biologic. We now have reliable tests for determining whether these differences are clinically significant or not. But what does our experience so far with biosimilars and originators tell us about these differences? We sat down with Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert who was part of the team that developed and presented evidence to the FDA for the first successfully approved US biosimilar (filgrastim; Sandoz). Paul helped explain these is

On this week’s episode, we sat down with David Senior, senior vice president of Market Economics at AmerisourceBergen. We discussed how the generics market developed in the United States and some of the challenges that it faced. We also talked about how the US generics industry could be instructive in understanding how biosimilar sales may develop over time.

On June 17, 2021, the Supreme Court ruled that opponents to the Affordable Care Act (ACA) did not have standing to challenge the law based on the constitutionality of the individual mandate, which provides for a penalty (currently $0) for those who do not obtain health care coverage. Had the Supreme Court struck down the entire ACA, it would have brought an end to the approval pathway for biosimilars that is contained within the ACA under the Biologics Price Competition and Innovation Act. We spoke with Stacie Ropka, PhD, a patent litigator and partner at Axinn, Veltrop & Harkrider in New York, New York, about the significance of this ruling and the conclusions that can be drawn from it.

Ping Cao, vice president of Business Development for Shanghai Henlius Biotech, discussed the company's current biosimilar development plans and the process for getting regulatory approval for biosimilars in China.

As the US biosimilar industry continues to expand, physicians, payers, and pharmaceutical companies have been at the forefront of the discussion on how to increase biosimilar uptake and education efforts. However, pharmacists also have a role to play in sharing information and encouraging uptake. The lack of interchangeability designations for US biosimilars prevents pharmacists from being able to switch out costly originator drugs with more affordable biosimilars. They must get approval from a physician first. There are other ways, though, that pharmacists can help uptake efforts. We sat down with Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health to discuss the power that pharmacists have in facilitating biosimilar uptake in the United States and what health care organizations can do to empower pharmacists further.

In March 2021, the National Comprehensive Cancer Network’s (NCCN) Oncology Research Program, in partnership with Pfizer, announced 10 research projects that will receive funding to develop innovative ways to improve biosimilar adoption in the oncology space. For this Not So Different series, The Center for Biosimilars® is spotlighting 3 projects to improve perception of biosimilars, promote biosimilars as a therapy choice, and encourage payers to prefer biosimilar use. In this third part, we spoke with Hong-Phuc Nguyen, PharmD, director of the pharmacy clinical network at City of Hope in Duarte, California. Dr Nguyen discussed how his project titled “Challenges to Biosimilar Adoption in Community Oncology Due to Diverse Payer Preferences for Different Biosimilars” will address how payer formulary decisions can improve or stall biosimilar uptake and acceptance.

In March 2021, the National Comprehensive Cancer Network’s (NCCN) Oncology Research Program, in partnership with Pfizer, announced 10 research projects that will receive funding to develop innovative ways to improve biosimilar adoption in the oncology space. For this Not So Different series, The Center for Biosimilars® is spotlighting 3 projects to improve perception of biosimilars, promote biosimilars as a therapy choice, and encourage payers to prefer biosimilar use. In this second part, we spoke with Muhammad Shaalan Beg, MD, director of GI Medical Oncology at UT Southwestern Medical Center. Dr Beg discussed how his project titled “Developing a Clinical Decision Support Tool for Biosimilar Use in Oncology” will make it easier for physicians to choose biosimilars for their patients.

In March 2021, the National Comprehensive Cancer Network’s (NCCN) Oncology Research Program, in partnership with Pfizer, announced that 10 research projects have been chosen to receive funding to focus on innovative ways to improve biosimilar adoption in the oncology space. For this 3-part series of Not So Different, The Center for Biosimilars® has chosen 3 projects that relate to improving perception of biosimilars, choice of biosimilars, and payer preferences for biosimilars. In this first part, we spoke with Claire Saxton, vice president of education at Cancer Support Community, a worldwide patient and family advocacy organization that provides financial support and navigation services. Saxton discussed how her project titled “Frankly Speaking About Cancer: Biosimilars—Researching Oncology Patient and Caregiver Perceptions” will help address the current perception issues surrounding biosimilars.

Maria Manley, LLM, a life sciences expert, talks about how the United Kingdom’s exit from the European Union has changed the regulatory landscape for biologics.

Juliette Petit, MD, a French rheumatologist, talks about her recent study showing that nurses can help curb patient fears and prevent a possible nocebo effect when switching them to a biosimilar.

State Representative Jennifer Schultz (D, Duluth) explains how her bill requiring payers to cover all approved biosimilars and reference products would save money and improve access.

Before the battle for market share gets started, the courtroom is the OK Corral for biosimilar developers and reference product manufacturers, who duke it out over patents  to determine how soon biosimilars can enter the marketplace. We spoke with Alexandra Valenti, JD, and Rob Cerwinski, JD, Goodwin partners and senior editors of the updated Guide to Biosimilars litigation and Regulation in the US about some of the key developments.

Anar Dossa, director of Pharmacy Services at Pacific Blue Cross, discusses the company projections and challenges that have come with implementing British Columbia's biosimilars initiative.

We sat down with Sarfaraz Niazi, PhD, an adjunct professor and biosimilar industry expert, to discuss the potential impact high-concentration adalimumab products could have on the US market.

In late 2020, Boehringer Ingelheim (BI) filed a citizen’s petition requesting the FDA to alter its definition of the word “strength” as used in a section of the Biologics Price Competition and Innovation Act (BPCIA). As of right now, the term is used in regard to parenteral solutions and does not allow a biological product to be licensed as a biosimilar or an interchangeable biosimilar if any variation in the volume of inactive drug content exists, even if the amount of active drug content remains consistent with the reference product. The company argued that the current definition permits originator manufacturers to continue to develop follow-on products by only slightly changing the formulation in order to prevent biosimilar competitors from obtaining market share and goes against the goals of the BPCIA and the intention of Congress when the BPCIA was passed. We spoke with Steven Lucio, PharmD, BCPS, vice president of Pharmacy Solutions for Vizient, to discuss his thoughts on B

China’s regulatory reforms and policy enhancements bode well for a thriving biosimilars industry.

Recently, one of our Advisory Board members, Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health, wrote an opinion piece on the status of ophthalmology medications and the potential for ophthalmology biosimilars. We spoke with her to learn more about this topic and her opinions on what needs to be done to accelerate biosimilar use in this growing therapeutic area.

Charles Bennett, MD, PhD, a hematologist and oncologist and professor in the Clinical Pharmacy and Outcomes Sciences Department of the College of Pharmacy at the University of South Carolina, served as lead author on a recent paper about the progress of oncology biosimilars. We spoke to him about the some of the findings of his study and how pay-for-delay schemes have somewhat stalled the biosimilar market.

Sean McGowan, senior director of Biosimilars at AmerisourceBergen, talked about how 2020 has impacted biosimilar development and his predictions for the industry going forward.

The biosimilar market in the United States has had a difficult start since the launch of the first biosimilar in 2015, facing many legal, regulatory, and policy barriers that stall market entry for many FDA approved products, slow down adoption rates and price drops, and discourage physician and patient use of biosimilars. Although some may look at the market and only see its flaws, some experts have hope for the market to change and flourish. We sat down with Dr. Marcus Neubauer, MD, chief medical officer of The US Oncology Network, Kathryn Tong, MBA, vice president of Payer, Pharmacy, Analytics & Transformation for McKesson, and Tommy Pourmahram, vice president of Multi-Source & Analytics for McKesson to discuss some of the factors currently holding back US biosimilar adoption, what reforms are needed to improve it, and what stakeholders can already do to help.

On October 28, the Community Oncology Alliance’s (COA) hosted their virtual Payer Exchange Summit on Oncology Payment Reform which featured a panel entitled “Biosimilar Opportunities, Challenges, and Realities.” The panel, which featured Kathy Oubre, MS, chief operating officer at the Pontchartrain Cancer Center in Louisiana and member of the board of directors for COA, discussed some of the current challenges and barriers to uptake for biosimilars. Kathy’s practice has been longtime users of biosimilars, and Kathy regularly advocates for their use. In a discussion with The Center for Biosimilars®, Kathy expanded on some of the topics she mentioned in the panel and offered other practices that may be wary of biosimilars insight into the potential benefits they could see by using them more.

In a recent study, investigators focused on net spending on specialty medicine after manufacturer rebates. What they found was a sharp rise in net specialty drug spending, but they also noted that use of rebates was rapidly increasing, too. This was true for both public and private payers. We discussed these findings with lead study author Steven C. Hill, PhD, a senior economist with the Division of Research and Modeling, Center for Financing, Access and Cost Trends, at the Agency for Healthcare Research and Quality in Rockville, MD.

There has been much debate recently whether comparative clinical efficacy trials are really necessary for demonstrating that a biosimilar candidate is equivalent to a reference product. Many argue that they contribute little to the weight of evidence available from other testing required by regulatory authorities, such as the FDA and the European Medicines Agency. A recent study of costs of these trials showed that they actually may end up costing more to do than the pivotal trials that led to the approvals of originator drugs. We sat down with Nancy J. Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs, for her take on these requirements and whether they add meaningful data for the purposes of biosimilar acceptance.

During 7 months of combatting the coronavirus disease 2019 (COVID-19) pandemic, US health care practices, especially in oncology, had to completely modify how they could safely treat patients. They may have reduced waiting room capacity, barred caregivers from attending appointments with patients, increased telehealth usage, or reworked priorities and postponed decisions. Some health care experts believe the pandemic will improve the overall uptake of biosimilars because it has made cost savings more important. Many patients face financial hardships as a result of the crisis. We sat down with Kathy Oubre, chief operating officer at the Pontchartrain Cancer Center in Louisiana, president of the Louisiana Medical Group Management Association, and a member of the board of directors for the Community Oncology Alliance, to discuss what practices had to do without during the COVID-19 crisis and how biosimilar access has been affected.

A recent survey conducted by the American College of Rheumatology (ACR) indicated that a large portion of patients with rheumatic diseases were unsure if they had been prescribed a biosimilar before, suggesting a major knowledge gap among patients on how biosimilars differ from reference biologics. Additionally, the survey showed a 52% decline in the percentage of respondents who said they were currently being treated by a rheumatologist, vs the number under treatment a year earlier. Patients also reported that wait times to be seen by a rheumatologist increased between 2019 and 2020. Both of these findings were likely partly due to the coronavirus disease 2019 (COVID-19) pandemic that has changed how practices conduct business and deprived some patients of the economic means and health insurance to continue seeing their provider. We sat down with Kanika Monga, MD, a rheumatologist at Houston Methodist Hospital in Texas and a member of the ACR’s Communication and Marketing Committee,

We sat down with Wayne Winegarden, PhD, a senior fellow in business and economics at the Pacific Research Institute (PRI) and director of PRI's Center for Medical Economics and Innovation, to discuss why the FDA’s implementation of the Safe Importation Action Plan is so controversial.

As summer fades away and the United States prepares for a potential second wave of coronavirus disease 2019 (COVID-19) cases, many are worried that economic impacts and rising health care costs will continue unless action is taken. Europe’s competitive biosimilar market has proven that biosimilars have the potential to lower costs. But with existing barriers, such as lack of education and payer oversight of formularies, and the continuing pandemic, there is some debate on whether biosimilars will have the same impact in the United States. We sat down with Julie Kennerly-Shah, PharmD, assistant director of Pharmacy at the Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute to discuss how biosimilars can help curb costs in the time of COVID-19 and beyond.

A major barrier to biosimilar uptake in the United States involves interchangeability, which is a regulatory designation given by the FDA that allows for switches between a reference product and a biosimilar to occur at the pharmacy level. Currently, there are no biosimilars that have received interchangeability status. Additionally, now that insulin products are regulated under the Biologics Price Competition and Innovation Act as a result of a regulatory rule change that occurred in March, biosimilar insulin products also may receive interchangeable designations. We sat down with Representative Glenn Grothman [R-Wisconsin], the author of HR 8190, a bill that would waive interchangeability requirements for biosimilar insulins, to discuss why this bill is needed for Americans and what it could mean for future biosimilar legislation.

Being based in Europe can have unique challenges for a company like Polpharma Biologics, a contract development and manufacturing organization (CDMO) with facilities in Poland and the Netherlands that specializes in biologics. Despite facing hurdles such as navigating partnerships to commercialize in multiple markets, developing complex molecules for international partners, and figuring out how to handle coronavirus disease 2019 (COVID-19) with facilities in 2 countries, Polpharma Biologics has grown to become a powerhouse, having 7 biosimilars in its pipeline and partnerships with Sandoz and Bioeq. We sat down with Alexandra Moulson, vice president of Strategy, Programs, and Portfolio at Polpharma Biologics to discuss how Polpharma Biologics and other CDMOs function and how companies choose which molecules to develop.

With the cost of biopharmaceuticals on the rise, employers are looking to biosimilars as a way to cut costs for themselves and their employees now more than ever. However, because the decision-making power for formularies rests mostly with payers and pharmacy benefit managers (PBMs), employers have seen few biosimilars added to their lists despite there being an increase in the number of biosimilar products that are on the US market. We sat down with Cheryl Larson, president and CEO of Midwest Business Group on Health (MBGH), an employer coalition based in Chicago, Illinois, to discuss the current obstacles employers face in getting biosimilars added to their formularies and what steps they can take to get around them.

In August, Samsung Bioepis, a biopharmaceutical manufacturer based in the Republic of Korea, received European Commission (EC) marketing authorization for its bevacizumab biosimilar, Aybintio. The EC approved Aybintio for all indications of the reference product, Avastin, including colorectal, breast, and lung cancer. Although Aybintio will increase price competition in Europe, how the individual biosimilar will fare against its already established competitors remains to be seen. We sat down with Jonathan Sweeting, head of Samsung Bioepis’ European business, to discuss the steps leading up to the approval of Aybintio and what the current bevacizumab market in Europe looks like.

The use of 4-letter suffixes for biologics has been a source of controversy in the United States since the FDA’s guidance on naming was released in 2015. The guidance stated that all newly approved biosimilars, interchangeable products, and originator biologics would add a 4-letter suffix to the end of the nonproprietary name, or molecule name, of the drug. However, the FDA revised their guidelines in 2019, and many originator manufacturers were relieved to find that they would not have to add a suffix retrospectively to products already on the market. Although many argued that the suffixes cause confusion, some said suffixes add clarity distinguishing biologics from one another. We sat down with Nancy Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs (ACMA) to discuss the true impact that these suffixes have on biosimilar perception and whether the United States has the right idea about using them.

We sat down with Carter Thorne, MD, FRCPC, former president of the Canadian Rheumatology Association and chief of the Division of Rheumatology and director of The Arthritis Program at Southlake Regional Health Centre in Newmarket, Ontario, to discuss the current status of Canada’s comfort level with biosimilars and what he sees for the future of switching policies.

A market’s structure and incentives are critical in ensuring that companies that develop medications like biosimilars have a competitive environment to thrive. Several countries in Europe implement tender systems, which are used to promote the lowest-cost biosimilar and may discourage competitors from contending after an unsuccessful bid. However, 2 officials of Medicines for Europe designed a scorecard of European markets to show which have robust biosimilar competition and which do not. We sat down with Adrian van den Hoven, director general of Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, to discuss their scorecard report for biosimilar access and what European countries they feel need the most work.

We sat down with an author of the opinion piece, Dorothy McCabe, PhD, the executive director of clinical development and medical affairs, immunology and biosimilars at Boehringer Ingelheim Pharmaceuticals and co-chair of the Biosimilars Forum education committee, to discuss what more needs to be done to combat biosimilar misinformation and how patients and physicians can help the cause.

Welcome to Not So Different, a podcast from The Center for Biosimilars®. I’m your host, Assistant Editor Skylar Jeremias. Biologic drug development requires complex processes to obtain desired results, and biosimilar manufacturing is no exception. However, biosimilar developers often run into complications when seeking approval from regulatory authorities. A recent study of failed applications for biosimilar approval revealed multiple reasons why biosimilar applications in the United States and Europe have been such a challenge. We sat down with Anurag Rathore, PhD, lead author of the study and coordinator of the Center of Excellence for Biopharmaceutical Technology in Delhi, India, to discuss the findings from this study and how biosimilar corporations can learn from them.

With its infliximab biosimilar, CT-P13 (Inflectra, Remsima) is undergoing trials as a possible treatment for coronavirus disease 2019 (COVID-19), Celltrion Healthcare also has ambitious plans to launch 1 new biosimilar per year through 2030. We sat down with Byoungseo Choi, the head of marketing for Celltrion Healthcare, to discuss exactly how this plan is going to work, the company’s current biosimilar pipeline, and its expectations for how their products will perform.

We sat down with Ryan Haumschild, PharmD, director of pharmacy at Emory Healthcare, to discuss how Emory's biosimilar utilization program has empowered biosimilar utilization within Emory and how Emory’s initiatives could be implemented on a larger scale.

Many physicians are wary about prescribing biosimilars, worrying that they are not as safe and effective as their reference products. Additionally, fears could be worsened as there have disturbing accounts of patients developing serious medical conditions as a result of switching insulin products. However, study results presented at the American Diabetes Association 80th Scientific Sessions online conference concluded that increased risks of hypo- and hyperglycemia as a result of switching from insulin degludec (iDeg) to another insulin stem from physicians administering inappropriate doses when switching entire insulin products. Investigators believe this is a consequence of physicians having a poor understanding of the pharmacodynamics and pharmacokinetics of iDeg. We sat down with Dr. Jing Chao, an assistant professor of medicine and metabolism, endocrinology and nutrition at the University of Washington in Seattle and one of the lead investigators of this study to discuss the f

Recently, Pfizer announced its pegfilgrastim biosimilar (Nyvepria) was approved by the FDA, which marks the first biosimilar approval this year. Although many expected more approvals earlier in the year, experts wonder if the race to find a revolutionary treatment and vaccine for coronavirus disease 2019 (COVID-19) slowed down the approval process and biosimilars have had to take a back seat for the time being. We sat down with Nick Mitrokostas, an intellectual property lawyer and partner at Goodwin's IP Litigation group, to discuss how this new approval will affect the biosimilar market and what he sees for the rest of 2020.

Biosimilar manufacturers have to overcome many hurdles in order for their products to be successful in the US market. Some of those hurdles are systemic, such as reimbursement systems that eliminate incentives for physicians to prescribe biosimilars. Some are through direct actions by reference manufacturers to prevent competition, such as patent thickets. And some limit savings for patients, such as cost sharing. However, advocacy groups such as the Association for Accessible Medicines, or AAM, are looking to change things on a legislative level. We sat down with Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the AAM, to discuss some of the advocacy changes the organization is looking to advance and their chances of approval.