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Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab.

AbbVie filed a complaint with the US International Trade Commission in relation to Alvotech’s AVT02, alleging the misuse of trade secrets.  The US District Court dismissed the trade secrets lawsuit brought by AbbVie against Alvotech also relating to AVT02 in October 2021.

Alvotech announced that the EC has approved AVT02 (100mg/mL biosimilar adalimumab), following the positive recommendation made by the CHMP in September 2021.

The FDA approved Eli Lilly’s Rezvoglar® (biosimilar insulin glargine).

Hyphens Pharma announced that it has signed an exclusive license and supply agreement with DKSH’s subsidiary Favorex Pte Ltd for the commercialisation of Alvotech’s proposed biosimilar ustekinumab in Singapore, Malaysia and the Philippines.

Xbrane Biopharma announced it is developing two new biosimilar candidates referencing Keytruda® (pembrolizumab) and Darzalex® (daratumumab).

Samsung Bioepis announced that SB12 (proposed eculizumab biosimilar) met all the endpoints in a Ph I study.