FDA panel recommends approval of Celltrion biosimilar

An advisory committee at the US Food and Drug Administration (FDA) has said that pharmaceutical company Celltrion’s proposed biosimilar used to treat Crohn’s disease and rheumatoid arthritis should be approved for sale.

Already registered?

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk

More on this story

Americas

Court upholds $83m sequencing verdict and sets royalty rate

17 June 2026 A cancer diagnostics company has lost its bid to overturn a jury verdict in a major patent dispute that has also spawned parallel proceedings before the Federal Circuit and PTAB.

Americas

Amgen and subsidiary dealt $20m blow over rodent antibody tech

15 June 2026 Unanimous jury finds willful infringement, with the possibility of a trebled award and a much larger feud still to come.

Americas

Moderna: BioNTech is claiming work ‘it never did’

12 June 2026 In a strong response to BioNTech, Moderna argues its next-gen vaccine is built on a fundamentally different design from the German biotech’s—setting up a scrap over whether a key patent should have been granted.

More features

Court upholds $83m sequencing verdict and sets royalty rate

Exclusive: ‘Cultural differences are an asset’ at the UPC

Amgen and subsidiary dealt $20m blow over rodent antibody tech

Ex-Simmons head of IP joins Carpmaels & Ransford

Moderna: BioNTech is claiming work ‘it never did’

Siemens ordered to recall mammography device across European countries

MoFo bags IP trial duo with 50 years’ combined experience

US biotech fires trade secrets suit at Chinese pharma group

FDA panel recommends approval of Celltrion biosimilar

More on this story

Editor's picks

Editor's picks

More features