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On 18 February 2025, Regeneron and Sanofi announced that the US FDA has accepted their sBLA for priority review of Dupixent® (dupilumab) for the targeted treatment of bullous pemphigoid (BP).  The FDA’s decision is expected by 20 June 2025.  If approved, Dupixent® will be t...

On 18 February 2025, Alvotech and Teva announced that the US FDA has accepted for review a Biologics Licence Application (BLA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg).  The companies expect that regulatory approval will be obtained ...

On 17 February 2025, Boan Biotech announced that the Journal of Bone Oncology published Phase III trial results for its biosimilar denosumab (Boluojia®/BA1102, formerly code-named LY01011), demonstrating comparable efficacy and safety to reference product, Amgen’s Xgeva®.  ...

The Australian Financial Review reports that on 17 February 2025, Novo Nordisk confirmed that Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® (semaglutide) as an adjunct to standard of care therapy to reduce the risk of major ...

On 17 February 2025, Formycon announced that it will be prematurely terminating the “Lotus” Phase 3 trial of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab).  According to Formycon, based on “intensive scientific dialogue” with the US FDA, it has concluded that the Ph...

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 Xgeva® (denosumab), respectively.  The biosimilars are approved for the same indications ...

On 14 February 2025, Galderma announced that the European Commission has approved Nemluvio® (nemolizumab) for both moderate to severe atopic dermatitis and prurigo nodularis.

According to Galderma, Nemluvio® is the first approved mAb specifically targeting IL-31 rece...

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), for the improvement of glycaemic control in adults and paediatric patien...

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® (tocilizumab), for rheumatoid arthritis (RA).  In the same announcement, Celltrion also confi...