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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.

Regeneron announces $4.07 billion in 2018 US net sales for Eylea®, as it awaits the commencement of new clinical trials for a high dose formulation.  Additionally, the FDA has assigned 13 May 19 as the action date for a potential new indication in diabetic retinopathy.

Samsung Bioepis announces partnership with 3SBio to commercialise biosimilars in China. Under the agreement, Samsung Bioepis will be be responsible for manufacturing and supplying the products, while 3SBio will be responsible for regulatory registration and commercialisatio...