Pearce IP BioBlast®: w/e 17 December 2021

by , | Dec 21, 2021

11 Dec 21 | Samsung Bioepis announced that SB12 (proposed eculizumab biosimilar) met all the endpoints in a Ph I study.

13 Dec 21 | Xbrane Biopharma announced it is developing two new biosimilar candidates referencing Keytruda® (pembrolizumab) and Darzalex® (daratumumab).

14 Dec 21 | 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.

17 Dec 21 | EU | Alvotech announced that the EC has approved AVT02 (100mg/mL biosimilar adalimumab), following the positive recommendation made by the CHMP in September 2021.

17 Dec 21 | US | 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.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

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