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Sep 19, 2025
On 19 September 2025, Celltrion announced that it will begin the European launch of Omlyclo®, biosimilar to Genentech’s Xolair® (omalizumab), in Norway. The announcement comes only 9 days after Celltrion said that it was set to “launch in Europe as a ‘first mover’ within the year”.
Sep 19, 2025
On 19 September 2025, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare for 3 biosimilars:
Sep 19, 2025
On 19 September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its September meeting, adopting positive opinions for the following nine biosimilars:
Sep 19, 2025
On 19 September 2025, Aurobindo Pharma subsidiary, CuraTeQ Biologics, announced positive results from its Phase 3 trial of BP16, biosimilar to Amgen’s Prolia® (denosumab).
Sep 19, 2025
On 19 September 2025, Shanghai Henlius and Organon announced that the European Commission has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, for all reference indications.
Sep 19, 2025
On 19 September 2025, Johnson & Johnson announced that the FDA has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).
Sep 18, 2025
On 18 September 2025, Celltrion announced that Health Canada has granted approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications.
Sep 18, 2025
On 18 September 2025, Samsung Bioepis’ Opuviz®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), was approved by Australia’s Therapeutic Goods Administration (TGA) in 2 presentations:
Sep 17, 2025
On 17 September 2025, Biocon Biologics announced that it received FDA approval for denosumab products Bosaya™ and Aukelso™, biosimilars to Amgen’s Prolia® and Xgeva®, respectively. The FDA granted provisional interchangeability designation for Bosaya™ and Aukelso™ for all approved indications.
Sep 17, 2025
On 17 September 2025, Formycon announced that Klinge Biopharma has entered a semi-exclusive licence agreement with French ophthalmology laboratory, Horus Pharma, for the commercialisation of FYB203
Sep 17, 2025
On 17 September 2025, Alteogen announced that the European Commission has approved Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).
Sep 17, 2025
On 17 September 2025, Alvotech filed a petition for post grant review of Regeneron’s patent US12168036 entitled “Methods for Treating Angiogenic Eye Disorders with High Doses of VEGF Receptor Fusion Proteins”.
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