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...
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By Naomi Pearce | 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...
By Bioblast Editor | Dec 20, 2021
Coherus announced that the FDA has approved Yusimry™ (biosimilar adalimumab). Coherus plans to launch Yusimry™ in the US on or after 1 July 2023 in accordance with a 2019 agreement with AbbVie.
By Bioblast Editor | Dec 20, 2021
Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab.
By Bioblast Editor | Dec 17, 2021
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.
By Bioblast Editor | Dec 17, 2021
Alvotech announced that the EC has approved AVT02 (100mg/mL biosimilar adalimumab), following the positive recommendation made by the CHMP in September 2021.
By Bioblast Editor | Dec 17, 2021
The FDA approved Eli Lilly’s Rezvoglar® (biosimilar insulin glargine).
By Naomi Pearce | Dec 16, 2021
In early November Pearce IP reported on a number of Federal Court decisions which appear to indicate flaws in the Australian Patent Office’s interpretation of the eligibility requir...
By Naomi Pearce | Dec 15, 2021
Vehicle Monitoring Systems Pty Ltd v SARB Management Group Pty Ltd [2021] FCAFC 224
Date:
Venue:
Delegate:
08 December 2021
Fu...
By Bioblast Editor | Dec 14, 2021
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.
By Naomi Pearce | Dec 13, 2021
06 Dec 21 | AU | Australia’s TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) for the treatment of adults with coronavirus who do not require supplemental oxygen and ...
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