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Aug 12, 2025
On 12 August 2025, the Swiss Federal Patent Court upheld Samsung Bioepis’ invalidity action against the Swiss and Liechtenstein part of Janssen Biotech’s European Patent 3883606. Janssen’s ‘606
Aug 11, 2025
On 11 August 2025, Australia’s Therapeutic Goods Administration (TGA) approved a new brand of Novartis’ ofatumumab:
Aug 7, 2025
On 7 August 2025, Sandoz announced that it is streamlining the clinical development programs for its nivolumab and ocrelizumab biosimilars, following “ongoing encouraging and favourable
Aug 6, 2025
On 6 August 2025, Celltrion announced that the US FDA has approved an expanded indication for its IV formulation of Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of
Aug 6, 2025
On 6 August 2025, Intas Pharmaceuticals, and its global subsidiaries operating under the Accord brand, announced the successful acquisition of Udenyca®, biosimilar to Amgen’s Neulasta®
Aug 5, 2025
On 5 August 2025, Actor Pharmaceuticals filed legal proceedings against Regeneron and Bayer in the Australian Federal Court. While the details of the proceedings have not yet been published, it is expected
Aug 5, 2025
On 5 August 2025, Polpharma Biologics and Fresenius Kabi announced that they have entered into a global licensing agreement (excluding Middle East & North Africa) for the commercialisation of PB016
Aug 5, 2025
On 5 August 2025, CivicaScript®, LLC announced that it will distribute Fresenius Kabi’s unbranded ustekinumab-aauz, biosimilar to J&J/Janssen’s Stelara®, in the US from 1 January 2026. CivicaScript
Aug 5, 2025
On 5 August 2025, Kashiv BioSciences and MS Pharma announced that they entered into a licence and supply agreement for Kashiv’s ADL-018, biosimilar to Novartis’ Xolair® (omalizumab), for the
Aug 4, 2025
On 4 August 2025, Australia’s Therapeutic Goods Administration (TGA) approved Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), in two pre-filled pen (PFP)
Aug 4, 2025
On 14 July 2025, Fresenius Kabi filed petitions for IPR (inter partes review) against Regeneron’s US Patent No. 11,084,865 to ophthalmic formulations of aflibercept and US Patent No. 10,828,345 to
Aug 4, 2025
On 4 August 2025, Celltrion announced that, according to market research firm IQVIA, Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), reached 24% market share in Europe in Q1 2025, up
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