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Sep 26, 2025
On 26 September 2025, Shanghai Henlius announced that the first patient has been dosed in its phase 1 multicentre clinical trial for HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab).
Sep 26, 2025
On 26 September 2025, Amneal Pharmaceuticals announced that it submitted a Biologics License Application (BLA) to the US FDA for ADL-018 (omalizumab), biosimilar to Novartis’ Xolair®.
Sep 25, 2025
On 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).
Sep 24, 2025
On 24 September 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has instructed Intas Pharmaceuticals to submit a revised protocol for its proposed biosimilar pembrolizumab Phase I/III clinical trial.
Sep 24, 2025
New Zealand’s drug funding agency, Pharmac, has opened for public consultation a provisional agreement with Roche to fund a package of Roche drugs, including subcutaneous formulations of biologics previously only funded as IV treatments.
Sep 24, 2025
On 24 September 2025, , Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for the months of July, August and September.
Sep 23, 2025
On 23 September 2025, Bristol Myers Squibb announced that the Institut national d’excellence en santé et en services sociaux (INESSS) has issued a positive recommendation for the reimbursement of Opdivo® SC…
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)…
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