Pearce IP BioBlast®: f/e 31 December 2021

20 Dec 21 | US | Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab.

20 Dec 21 | US | The FDA approved Eli Lilly’s Rezvlogar® (biosimilar insulin glargine).

20 Dec 21 | US | 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.

22 Dec 21 | EU | Sandoz announced that it has submitted a BLA to the EMA for a proposed biosimilar trastuzumab.

23 Dec 21 | Theramex and Enzene Biosciences announced that they have entered into an agreement for the development and commercialisation of biosimilar tocilizumab.  The product will be available in parenteral vials, PFS and autoinjectors from 2026 in Europe, the UK, Switzerland and Australia.

24 Dec 21 | CA | Health Canada approved Celltrion’s Yuflyma® (100mg/mL biosimilar adalimumab) for all indications as Humira®.

24 Dec 21 | CN | Innovent Biologics announced that China’s NMPA has accepted the supplemental New Drug Application for sintilimab plus biosimilar bevacizumab injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer who progressed after EGFR-TKI therapy.

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