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Sep 23, 2025
On 23 September 2025, GxP News reported that Russian company, Generium, has obtained registration of the first Russian biosimilar to Novartis’ Ilaris® (canakinumab).
Sep 23, 2025
On 23 September 2025, Korea Biomedical Review reported that Sam Chun Dang’s SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) was approved in both Japan and Korea in vial and pre-filled syringe (PFS) forms.
Sep 22, 2025
On 22 September 2025, Celltrion announced that Japan’s Ministry of Health, Labor and Welfare has approved Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab),
Sep 22, 2025
On 22 September 2025, Enzene Biosciences announced the Indian launch of its biosimilar to Roche’s Perjeta® (pertuzumab).
Sep 22, 2025
Australia’s Therapeutic Goods Administration approved Amgen’s high-concentration Amgevita® (100mg/ml), biosimilar to AbbVie’s Humira® (adalimumab)…
Sep 21, 2025
On 21 September 2025, Medical Dialogues reported that Biocon has received recommendations from India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to import and market its biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) in India
Sep 19, 2025
On 19 September 2025, MSD announced that Keytruda Qlex™ (pembrolizumab and berahyaluronidsase alfa-pmph; MK-3475A) has been approved by the FDA for subcutaneous use in adults…
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.
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