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Robert Cerwinski: Reference Product Sponsors and Biosimilar Development
Robert Cerwinski, JD, partner at Goodwin, discusses the challenges that reference product sponsors encounter when they also seek to develop biosimilars.
Transcript:
A very interesting question. What we see in the biosimilar space that we don’t see as often in the generic drug space are brand companies really aggressively pursuing biosimilars of competitor products. We do see companies like Amgen play both sides of the fence. We also see that, at least with respect to questions like “what are the requirements of the patent dance? Is it mandatory, is it not?”, Amgen has really had to be very careful in the line in takes.
As a biosimilar defendant, where the economic imperative is to get to market as fast as possible, whereas on the branded side every day of delay, every month of delay represents an economic advantage. We do see currently that companies that are playing both sides of the fence have to be very, very careful. Since a biosimilar can be quite profitable though, and since biosimilars present one way for branded companies to compete against their other branded competitors, I don’t think Amgen will be alone. I think we will continue to see branded companies really vigorously pursue biosimilar opportunities of competitor products.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On 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.
Breaking Down Biosimilar Barriers: Interchangeability
November 14th 2024Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join 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.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?
November 4th 2024The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.
