Not So Different: A Podcast from The Center for Biosimilars

In this special video episode of Not So Different, co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on clinical efficacy testing and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining action items for the agency.

In this insightful podcast episode, host Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), welcomes former Sandoz executive and biosimilar expert Hillel Cohen to discuss the evolving world of biosimilars. The conversation covers the scientific and regulatory landscape, touching on the progress in streamlining biosimila...

Co-hosts Craig Burton, executive director of the Biosimilars Council, and Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void." This special vodcast series provided by The Center for Biosimilars® was developed in partnershi...

Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that? Josh Canavan, head of pharmacy at RazorMetrics, provides insights into why, despite the substantial savings biosimilars offer, they still represent only 23% of the overall biologics market.

In today’s episode, we dive into the FTC’s second interim report on PBMs, exposing key issues like preferential reimbursement for affiliated pharmacies. The findings raise questions about drug pricing transparency and PBM accountability. Joining us is Joe Wisniewski, a PBM legislation and pricing expert from Turquoise Health, to discuss the report’s impact, biosimilars, and shifting regulation...

In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.

On this episode of Not So Different, we reflect on 2024 and this show in particular, taking audiences back through the most popular podcast episodes of the year.

On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.

On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.

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 mar...

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...

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...

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...

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.