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Oct 24, 2025
On 24 October 2025, Johnson & Johnson announced that the European Commission has approved a subcutaneous (SC) induction dose regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
Oct 24, 2025
On 24 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved Novo Nordisk’s Alhemo® (concizumab) for the prevention or reduction in the frequency of bleeding episodes (prophylaxis) in people aged 12 years and older with haemophilia A or B with inhibitors.
Oct 24, 2025
On 24 October 2025, IAM reported that the Munich Regional Court has granted Regeneron a permanent cross-border injunction against Formycon preventing launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), across 20 countries.
Oct 23, 2025
On 23 October 2025, Samsung Bioepis published its eleventh US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.
Oct 23, 2025
On 23 October 2025, Biocon Biologics announced that Health Canada has approved Biocon’s Yesintek™ and Yesintek™ IV (intravenous), biosimilars to Janssen’s Stelara® (ustekinumab), for moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and ulcerative colitis.
Oct 21, 2025
On 21 October 2025, African biotechnology company Bio Usawa announced that the Rwanda Food and Drugs Authority has granted market approval for its BioUcenta™, biosimilar to Genentech’s Lucentis® (ranibizumab), making the product the first ranibizumab biosimilar approved in Africa.
Oct 21, 2025
On 21 October 2025, Xbrane announced that the FDA has issued a Complete Response Letter (CRL) regarding its biosimilar ranibizumab, referencing Genentech’s Lucentis®.
Oct 21, 2025
On 21 October 2025, Formycon and Teva jointly announced the European launch of FYB201/Ranivisio®, biosimilar to Genentech’s Lucentis® (ranibizumab), in pre-filled syringe (PFS) presentation.
Oct 20, 2025
On 20 October 2025, Teva announced that it has entered into a licensing agreement with Prestige Biopharma for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab), across a majority of European markets.
Oct 20, 2025
On 20 October 2025, Santen Pharmaceutical announced that Santen Korea has entered into a promotion and distribution agreement in South Korea with Novartis Korea.
Oct 20, 2025
On 20 October 2025, Regeneron announced that it has settled its BPCIA litigation with Celltrion in relation to Eydenzelt®/CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg). Under the terms of the settlement, Celltrion is permitted to launch Eydenzelt® in the US on 31 December 2026.
Oct 17, 2025
On 17 October 2025, Samsung Biologics announced that its biosimilar operations will be spun off into a new holding entity, Samsung Epis Holdings, after the proposal was approved by shareholders at an Extraordinary General Meeting.
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