Q&A: Patent Attorney Provides Insight Into Biosimilar Legal ChallengesFebruary 7th 2023
Geoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on biosimilar legal challenges throughout 2022, providing insight on the inner workings of the patent dance and how a Supreme Court decision could have an impact on future cases.
Part 1: Samsung Bioepis Executive Shares Developer Perspective on Biosimilar Switching Studies, Clinical Efficacy TestingJanuary 23rd 2023
As part of a series of interviews, Kyung-Ah Kim, executive vice president of Samsung Bioepis, offered insight into how developers view the current biosimilars market, the relevance of interchangeability, and the usefulness of clinical efficacy testing.
Q&A: How Will Biobetters Fit Into the Growing Biologics Market? Celltrion Executive ExplainsAugust 6th 2022
In an interview with The Center for Biosimilars®, Hyoung Ki Kim, vice chairman and CEO of Celltrion Healthcare, breaks down the benefits of biobetters, how they differ from biosimilars, and how they could alter the future landscape of the biologics industry.
FDA Launches Searchable Database Intended to Replace Static Purple Book ListsFebruary 24th 2020
Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products.
Coherus, Accord Both Receive Positive CHMP Opinions for Pegfilgrastim BiosimilarsJuly 27th 2018
Drug maker Coherus announced today that it has received a positive opinion on its pegfilgrastim biosimilar, CHS-1701, from the European Medicines Agency’s Committee for Human Use (CHMP). Coherus plans to sell the drug under the name Udenyca. Separately, Accord Healthcare received a positive opinion for its own pegfilgrastim biosimilar, which it plans to market as Pelgraz.