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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
Aug 2, 2025
As reported by Medical Dialogues, India’s Central Drugs Control Organisation (CDSCO) has reviewed and accepted without objection a final Clinical Study Report (CSR) submitted by Intas
Aug 1, 2025
On 1 August 2025, the Pharmaceutical Benefits Scheme (PBS) published its Summary of Changes, which includes the following:
Aug 1, 2025
On 1 August 2025, the Korea Biomedical Review reported that Boryung launched Samsung Bioepis’ denosumab biosimilar (Xbryk™) in the Korean market, following its regulatory approval in May 2025.
Jul 30, 2025
On 30 July 2025, Sandoz and Evotec announced that they have signed a non-binding term sheet relating to Sandoz’s potential acquisition of Just-Evotec Biologics EU and its J.POD® biologics
Jul 30, 2025
On 30 July 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its November 2025 agenda, at which four Celltrion biosimilars will be considered:
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