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On 29 October 2025, Samsung Bioepis announced that it has entered into an Asset Purchase Agreement with Biogen in Europe for Samsung Bioepis’ two ophthalmology biosimilars: Byooviz® (biosimilar to Genentech’s Lucentis® (ranibizumab)) and Opuviz™ (biosimilar to Regeneron/Bay...

On 29 October 2025, the FDA announced proposed measures to make it faster and less costly to develop biosimilars, by simplifying biosimilarity studies, reducing unnecessary clinical trials and facilitating pharmacy level substitution.

In a new draft guidance, entitle...

On 27 October 2025, China Medical System Holdings Limited announced that its subsidiary, CMS Vision International Management Limited, has entered into a distribution agreement with Novartis Pharma Services AG for Lucentis® (ranibizumab) and Beovu® (brolucizumab).

Und...

On 27 October 2025, the FDA issued a Complete Response Letter (CRL) to Regeneron for its pre-filled syringe (PFS) supplementary BLA (sBLA) for Eylea HD® (aflibercept, 8mg).  The only issue cited in the CRL relates to unresolved inspection findings at Catalent, the manufactu...

On 24 October 2025, Johnson & Johnson announced that the European Commission has approved a subcutaneous (SC) induction dose regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequat...

On 24 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved Novo Nordisk’s Alhemo® (concizumab) for the prevention or reduction in the frequency of bleeding episodes (prophylaxis) in people aged 12 years and older w...

On 24 October 2025, IAM reported that the Munich Regional Court has granted Regeneron a permanent cross-border injunction against Formycon preventing launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), across 20 countries.  The permanent injunction follo...