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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...

Celltrion announces it will establish a direct sales network minimising sales partners, including for its biosimilar infliximab, Remsima®.

Coherus announces launch of pegfilgrastim biosimilar Udencya® in the US, confirming sales began on January 3rd.

Alteogen announces it has been granted a process patent for producing aflibercept biosimilar, ALT-L9.  Alteogen reports the process improves the productivity and quality of large-scale production of fusion proteins.