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In response to FDA approval of Eticovo®, Amgen and Roche file a suit alleging the infringement of five patents. Within the complaint, Amgen and Roche allege that Samsung failed to provide them with a copy of its aBLA or details of the manufacturing process, as well as faili...

FDA approves biosimilar etanercept Eticovo® for all eligible indications (RA, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis).

Xbrane commences Phase III trials for biosimilar ranibizumab candidate Xlucane®.

Sandoz reports results of long term studies (up to 54 weeks) on the efficacy, safety and immunogenicity of infliximab biosimilar.  This product was initially developed by Pfizer and acquired by Sandoz.

Sandoz and Roche settle long-running AU Federal Court dispute over rituximab biosimilar, allowing for the launch of Sandoz product Riximyo® “in the near future”.  The 2017 Federal Court proceedings before Burnley J were dismissed.

Selexis announces first biosimilar eculizumab approval in Russia through partnership with Generium. 

Health Canada approves Teva’s Truxima® for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis in adult patients.

Alvotech and Fuji Pharma announce exclusive agreement for the commercialisation of Stelara® biosimilar in Japan. Alvotech will be responsible for development and supply while Fuji Pharma will receive exclusive rights to commercialise the drug in Japan. This follows Fuji Pha...

Genentech files complaint against Pfizer in the District Court of Delaware alleging infringement of 22 patents and requesting a declaratory judgment of infringement of several of these patents.

Fresenius Kabi announces European Commission approval of biosimilar adalimumab, Idacio® for all indications.