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Sep 10, 2025
On 10 September 2025, the District Court of The Hague delivered judgment in Samsung Bioepis’ revocation action against Janssen’s EP 3 883 606 (the Janssen Patent)…
Sep 10, 2025
On 10 September 2025, Celltrion announced that it will present its global Phase 1 clinical trial results for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab)…
Sep 10, 2025
On 10 September 2025, Celltrion confirmed that it is planning the European launch of Omlyclo® (CT-P39), biosimilar to Genentech’s Xolair® (omalizumab)…
Sep 10, 2025
On 10 September 2025, Regeneron filed a patent infringement suit against Alvotech and Fisher Clinical Services UK Limited in the High Court of Justice for England & Wales.
Sep 9, 2025
On 9 September 2025, Sandoz announced that it has settled all US patent disputes with Regeneron relating to Sandoz’s Enzeevu®, biosimilar to Regeneron’s Eylea® (aflibercept).
Sep 8, 2025
On 8 September 2025, Justice Rofe of the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer a preliminary injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).
Sep 5, 2025
On 5 September 2025, the World Health Organisation (WHO) announced that it has updated its Model List of Essential Medicines (EML) to include pembrolizumab (including “quality assured biosimilars”)…
Sep 5, 2025
On 5 September 2025, consent orders were made by the US District Court for the District of New Jersey recording that Samsung Bioepis and Amgen have entered into a settlement agreement resolving pending BPCIA patent litigation in relation to denosumab.
Sep 4, 2025
On 4 September 2025, Celltrion announced that it has launched Steqeyma® (ustekinumab) and Omlyclo® (omalizumab) in Australia, biosimilars to J&J/Janssen’s Stelara® and Novartis’ Xolair®…
Sep 4, 2025
On 4 September 2025, Brazil’s National Health Surveillance Agency (Anvisa) announced that it seized a batch of a drug sold under the name Opdivo®…
Sep 2, 2025
On 2 September 2025, Polpharma Biologics S.A. and MS Pharma announced that they have entered into licensing agreements for the commercialisation of proposed biosimilar candidates to…
Sep 2, 2025
On 2 September 2025, Shanghai Henlius and Organon announced that the FDA has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, for all reference indications.
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