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The FDA announced that it will pilot a regulatory science program to advance the development of interchangeable products and improve the efficiency of biosimilar product development.  The program, set out briefly in the FDA’s Biosimilar User Fee Act (BsUFA) reauthorization ...

Biogen announced that the EMA has accepted the MAA for BIIB800 (biosimilar tocilizumab).  Biogen holds the rights to commercialise Bio-Thera’s product in all countries excluding China under an April 2021 agreement.

A new study reported that Intas Pharmaceuticals’ Razumab® (biosimilar ranibizumab) achieved comparable visual acuity outcomes to Lucentis® in patients with polypoidal choroidal vasculopathy.

Korea Biomedical Review reported that Samsung Bioepis will present on three scientific abstracts on its ophthalmology biosimilars, aflibercept and ranibizumab, at the American Academy of Ophthalmology 2022 between 30 September – 03 October.  Samsung Bioepis reported that in...

BioNTech and Pfizer have filed suit in the Patents Court of England and Wales seeking to invalidate two Moderna patents relating to COVID vaccine technology.  Moderna sued Pfizer and BioNTech for patent infringement in the US District Court for the District of Massachusetts...

Merck announced that Japan’s Ministry of Health has granted approval of Keytruda (pembrolizumab) for four new indications: in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, for patients with hormone receptor-...

Pulse News reported that Celltrion has received approval for Vegzelma™ (biosimilar bevacizumab) in Japan for the treatment of a number of indications including colorectal cancer, non-small cell lung cancer and metastatic breast cancer.