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The CHMP recommends granting approval for two AmAb biosimilars, Idacio® and Kromeya®. Both products are indicated for RA, psoriasis, psoriatic athritis and Crohn’s disease.

Coherus announces an 8th global deal with AbbVie for the commercialisation of biosimilar AmAb, under which Coherus has global, non-exclusive license rights which are royalty bearing.  Coherus’ US rights commence on 15 Dec 2023, just under a month after Momenta’s...

Amgen announces results of Phase 1/Phase 3 study of rituximab biosimilar candidate, confirming the study demonstrated favourable efficacy and safety profiles.

Alvotech announces development in biosimilar pipeline with $300 million raised through a private bond offering.

Bio-Thera announces commencement of Ph III trials of BAT1806, its proposed tocilizumab biosimilar. Results are expected in the second half of 2020.

FDA approves biosimilar trastuzumab for all eligible indications. This is Samsung Bioepis’ first oncology biosimilar to receive FDA approval.

Health Canada approves new indication for Erelzi®, allowing for the treatment of psoriatic arthritis. 

Celltrion announces success in litigation against Samsung Bioepis, invalidating Samsung Bioepis’s patent for biosimilar rituximab. 

Bio-Thera announces partnership with Cipla to commercialise BmAb candidate in emerging markets.

Samsung Bioepis obtains AU approval for Ontruzant®, biosimilar trastuzumab, in Australia.  This is the third biosimilar TmAb to be approved in AU, following Celltrion’s approval of Simabtra® in July 2018, and Mylan’s approval of Ogivri® in December 2018.