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The EMA accepts Prestige Biopharma’s application for trastuzumab biosimilar Tuznue®.

Health Canada approves Ogivri® for the treatment of HER2-positive breast cancer and HER2-positive metastatic stomach cancer. The product is the first TmAb biosimilar to be approved in Canada and is expected to be launched in the current quarter.

Genentech moves to dismiss Pfizer’s counter-claims, claiming that BPCIA legislation prevents any declaratory judgement as Pfizer did not comply with requirements during the ‘patent dance’.

Amgen receives Australian approval for biosimilar trastuzumab Kanjinti®, in 60mg, 150mg and 420mg dosages.

AbbVie announces global settlement with Boehringer Ingelheim. This is the 9th global deal AbbVie has entered into, with BI securing a US market entry date of 1 July 2023, after Amgen (31 Jan 2023) and Samsung Bioepis (30 Jun 2023), and before Mylan (31 Jul 2023), Fresenius ...

NeuClone confirms Ph1 trials of biosimilar ustekinumab will commence in the second half of 2019, as previously announced.

Federal Court affirms District Court finding Sandoz did not infringe Amgen’s ‘837 patent.

Federal Court affirms District Court finding Sandoz does not infringe Amgen’s ‘837 patent.

Innovent and Eli Lilly announce rituximab biosimilar IBI301 met primary endpoints in Phase III clinical trials and PK study.

Pfizer responds to Genentech’s complaint, seeking declaratory judgement of invalidity and noninfringement of all of the patents in Genentech’s complaint.