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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.

The European Medicines Agency’s ...

On 19 September 2025, Johnson & Johnson announced that the FDA has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).  The BLA for the SC regimen was accepted in...

On 18 September 2025, Celltrion announced that Health Canada has granted approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications.

This makes Celltrion’s Stoboclo® and Osenvelt® ...

On 18 September 2025, Samsung Bioepis’ Opuviz®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), was approved by Australia’s Therapeutic Goods Administration (TGA) in 2 presentations:

OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial ...

On 17 September 2025, Biocon Biologics announced that it received FDA approval for denosumab products Bosaya™ and Aukelso™, biosimilars to Amgen’s Prolia® and Xgeva®, respectively.  The FDA granted provisional interchangeability designation for Bosaya™ and Aukelso™ for all ...

On 17 September 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), has entered a semi-exclusive licence agreement with French ophthalmology ...

On 17 September 2025, Alteogen announced that the European Commission has approved Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).  According to Alteogen, Eyluxvi® is the first biosimilar developed by Alteogen through independent in-house research a...

On 17 September 2025, Alvotech filed a petition for post grant review of Regeneron’s patent US12168036 entitled “Methods for Treating Angiogenic Eye Disorders with High Doses of VEGF Receptor Fusion Proteins”.  The patent was granted on 17 December 2024 and relates to metho...

On 17 September 2025, Regeneron filed an application for leave to appeal the decision of Justice Rofe of the Federal Court of Australia refusing to award Regeneron/Bayer a preliminary injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®, biosimilar to Regener...

On 16 September 2025, First Word Pharma reported that Mitsubishi Tanabe Pharma Corporation’s (MTPC) contract with Janssen for co-promotion activities for Janssen’s Stelara® (ustekinumab) in Japan will end on 31 December 2025.

Under the co-promotion agreement, MTPC ha...