Here are the top 5 biosimilar articles for the week of May 22, 2023.
Hi, I’m Justina Petrullo for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilar articles for the week of May 22nd, 2023.
Number 5: Although the FDA has consistently edited its testing guidelines for biosimilar developers over the years, clinical testing is still very expensive and time-consuming. Sarfaraz K. Niazi, PhD, offered the FDA and companies a plan of action for reducing clinical testing expenses for biosimilar products.
Number 4: Authors of a new in vitro study said Sanofi’s biosimilar SAR341402, approved in June 2020 by the European Medicines Agency for use in insulin pumps, had similar stability compared with the originator under stress conditions in their experiments.
Number 3: Amneal Pharmaceuticals announced the launch of its pegfilgrastim biosimilar, Fylnetra (pegfilgrastim-pbbk), for the treatment and prevention of febrile neutropenia, making it the sixth biosimilar referencing Neulasta to enter the US market.
Number 2: As Celltrion Healthcare announced the launch of the biobetter version of Remsima (Remsima SC) in Brazil, the company shared the phase 3 plan for its ocrelizumab biosimilar to treat multiple sclerosis (MS).
Number 1: As Sandoz and Just-Evotec Biologics announced a new partnership, Celltrion secured tender wins in Italy and Belgium, and Alvotech began testing its golimumab biosimilar in patients with rheumatoid arthritis.
To read all of these articles and more, visit centerforbiosimilars.com.