Podcasts

This is part 1 of a series on National Comprehensive Cancer Network/Pfizer efforts to investigate issues of importance to biosimilar stakeholders.

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.

Key 2020-2021 updates to the Guide to Biosimilars litigation and Regulation in the US encompass antitrust litigation, preliminary injunctions, and a slowdown in litigation.

Anar Dossa, director of Pharmacy Services at Pacific Blue Cross, discusses the company's involvement with British Columbia's biosimilars switching program.

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.

We sat down with Steven Lucio, PharmD, BCPS, senior principal of Pharmacy Solutions for Vizient, to discuss Boehringer Ingelheim's recent citizen's petition to the FDA.

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

We spoke with Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health, about the status of ophthalmology biosimilars and her opinions on what needs to be accomplished for these agents to flourish.

We spoke to Charles Bennett, MD, PhD, a clinical pharmacy specialist, about his recent oncology biosimilars study and how pay-for-delay schemes have somewhat stalled the biosimilar market.

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

We sat down with a trio of experts to discuss the factors currently impacting biosimilar adoption, what reforms are needed to improve it, and what stakeholders can do to help.

Kathy Oubre, MS, chief operating officer at the Pontchartrain Cancer Center in Louisiana, discusses the value of biosimilars.

In an interview with The Center for Biosimilars®, Steven C. Hill, PhD, a senior economist with the Agency for Healthcare Research and Quality, discusses a recent study he co-authored on specialty drug spending.

We spoke with Nancy J. Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs, for her take on requirements for comparative efficacy trails and whether they add meaningful data for the purposes of biosimilar acceptance.

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 controversial.

We sat down with Alexandra Moulson, vice president of Strategy, Programs, and Portfolio at Polpharma Biologics to discuss how Polpharma Biologics and other contract development and manufacturing organization (CDMOs) function and how companies choose which molecules to develop.

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.

We sat down with Jonathan Sweeting, head of Samsung Bioepis’ European business, to discuss the steps leading up to the European approval of Aybintio and what the current bevacizumab market in Europe looks like.

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 suffixes have on biosimilar perception and whether they are appropriate for the United States.

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.

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 markets they feel need the most work.

We sat down with 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.

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.

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 this program has empowered biosimilar utilization within Emory and how Emory’s initiatives could be implemented on a larger scale.

We sat down with Jing Chao, MD, 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 findings of this study as well as how biosimilar insulins could pave the way for increased patient access.

We sat down with Joe Fuhr, PhD, professor emeritus of economics at Widener University in Chester, Pennsylvania, and an expert on antitrust health economics and pharmacoeconomics to discuss the current state of the biosimilar landscape and what he sees going forward.

In this episode of Not So Different, we sat down with Nick Mitrokostas, an intellectual property (IP) lawyer and partner at Goodwin's IP Litigation group, to discuss how the approval of Pfizer’s pegfilgrastim biosimilar (Nyvepria) will affect the biosimilar market and what he sees for the rest of 2020.