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 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.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In 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.
EHA Poster Shows Transfusion Avoidance Rates Were Comparable Between Eculizumab Biosimilar, Soliris
Published: June 15th 2024 | Updated: June 14th 2024A poster from the European Hematology Association’s (EHA) 2024 annual meeting in Madrid, Spain, showed similar rates of transfusion avoidance between patients with paroxysmal nocturnal hemoglobinuria who were administered reference eculizumab (Soliris) and those administered an eculizumab biosimilar (SB12).
New Data Show Safety of Ado-Trastuzumab, Trastuzumab Biosimilars in HER2+ Cancers
June 11th 2024Posters from the American Society of Clinical Oncology annual meeting showcased safety and efficacy data for a trastuzumab biosimilar and an ado-trastuzumab biosimilar in HER2-positive (HER2+) cancers.