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Oct 1, 2025
On 1 October 2025, Sandoz’s Erelzi®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in 50mg/mL syringe and pen devices.
Sep 29, 2025
On 29 September 2025, Fresenius Kabi announced that the US Centers for Medicare and Medicaid Services (CMS) assigned a permanent billing code for Conexxence® and Bomyntra®, biosimilars to Regeneron/Bayer’s Prolia® and Xgeva® (denosumab), respectively.
Sep 29, 2025
On 29 September 2025, Gedeon Richter and Hikma Pharmaceuticals announced they have secured FDA approval for Enoby™ (RGP-14-P) and Xtrenbo™ (RGP-14-P) (denosumab-qbde), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.
Sep 29, 2025
On 29 September 2025, Outlook Therapeutics announced that it has completed a Type A Meeting with the FDA to discuss the August 2025 complete response letter (CRL) declining Outlook’s BLA resubmission for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.
Sep 29, 2025
On 29 September 2025, Genmab A/S and Merus N.V. announced that they have entered into an agreement for Genmab to acquire all the shares of Merus in an all-cash transaction worth approximately USD 8 billion, with the deal anticipated to close early in the first quarter of 2026.
Sep 29, 2025
On 29 September 2025, Novartis announced that it plans to launch a US direct-to-patient (DTP) platform for Cosentyx® (secukinumab) from 1 November 2025, offering cash-paying patients access to the drug at 55% off the list price.
Sep 29, 2025
On 29 September 2025, Johnson & Johnson announced that the US FDA has approved an indication extension for Tremfya® (guselkumab) for the treatment of severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in children aged six and older, weighing at least 40 kg. J&J submitted the two supplemental Biologics Licence Applications (sBLAs) for these indications in December 2024.
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.
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