On 16 February 2025, Samsung Bioepis announced that the European Commission has approved Obodence™ (60mg pre-filled syringe) and Xbryk™ (120mg vial), biosimilars to Amgen’s Prolia® and
On 14 February 2025, Galderma announced that the European Commission has approved Nemluvio® (nemolizumab) for both moderate to severe atopic dermatitis and prurigo nodularis.
On 14 February 2025, the FDA approved Sanofi-Aventis US’s Merilog™ (injection, 10 mL)/Merilog™ SoloStar (injection, 3 mL) (insulin-aspart-szjj), biosimilars to Novo Nordisk’s Novolog® (insulin aspart),
On 13 February 2025, Celltrion announced that Korea’s Ministry of Food and Drug Safety has approved its subcutaneous formulation for Aptozma™/CT-P47, biosimilar to Roche’s Actemra®
On 13 February 2025, CSL announced that the European Commission has approved Andembry® (garadacimab) to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
On 13 February 2025, the US FDA approved Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb, SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively. The biosimilars are approved
On 12 February 2025, Qyuns Therapeutics Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has accepted the marketing authorisation application and supplemental application for QX001S
On 12 February 2025, Pfizer announced that the US FDA has approved Adcetris® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of adult patients with
On 12 February 2025, UCB announced that two-year data from the BE HEARD trials for Bimzelx® (bimekizumab) demonstrated sustained disease control in patients with moderate to severe
On 12 February 2025, New Zealand’s Pharmac announced that, from 1 March 2025, it will extend funding of Celltrion’s Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), for
On 11 February 2025, the Australian Therapeutic Goods Administration (TGA) approved Alovtech and Cipla’s Uteknix®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two formulations:
On 11 February 2025, Merck (known ad MSD outside the US and Canada) announced that Health Canada has approved Keytruda® (pembrolizumab) for the treatment of adults with resectable Stage
On 11 February 2025, Regeneron announced that the US FDA has accepted for review its resubmitted Biologics Licence Application (BLA) for linvoseltamab. Linvoseltamab, a BCMAxCD3
On 10 February 2025, Bio-Thera Solutions announced that it has entered an exclusive US commercialisation and licence agreement with Intas Pharmaceuticals for BAT2506 (golimumab), biosimilar to J&J’s Simponi® and Simponi Aria®.
On 10 February 2025, Pfizer and Astellas Pharma announced positive results from their Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The trial evaluated the efficacy and safety of
On 10 February 2025, the Scottish Medicines Consortium (SMC) issued its February 2025 decisions on medicines for reimbursement by NHS Scotland, including accepting three biologics and rejecting