Recent BioBlast® Updates

FDA Accepts Outlook Therapeutics’ BLA for Ophthalmic Bevacizumab

Nov 13, 2025

On 13 November 2025, Outlook Therapeutics announced that the US FDA has accepted its Biologics License Application (BLA) for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™ for wet AMD.

Sandoz & EirGenix Global Deal for Biosimilar Pertuzumab

Nov 12, 2025

On 12 November 2025, Sandoz and EirGenix announced a global licensing agreement for the commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab).

Henlius’ MAAs for Biosimilar Denosumab Accepted in UK

Nov 12, 2025

On 12 November 2025, Shanghai Henlius announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorisation applications (MAAs) for two denosumab injections: 60mg (Bildyos®; biosimilar to Amgen’s Prolia®) and 120mg (Bilprevda®; biosimilar to Amgen’s Xgeva®).

Russian Pembrolizumab Biosimilar Approved in Vietnam

Nov 11, 2025

On 11 November 2025, Viet Nam News, reported that the Vietnam Ministry of Health has granted marketing authorisation for Pembroria™, biosimilar to MSD’s Keytruda® (pembrolizumab), in Vietnam for a three-year period.

J&J’s Guselkumab Accessible through NHS Scotland for Crohn’s and UC

Nov 11, 2025

On 11 November 2025, Johnson & Johnson announced that the Scottish Medicines Consortium (SMC) has accepted Tremfya® (guselkumab) for use in NHS Scotland for adult patients with moderately to severely active Crohn’s disease

SPC Waiver Win for Alvotech – UK Court Rejects Regeneron/Bayer Injunction Against Alvotech and its CMO

Nov 10, 2025

On 10 November 2025, Alvotech announced that the UK High Court has rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s AVT06 (Mynzepli®), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).

Bio-Thera & Dr Reddy’s Partner on Secukinumab Biosimilar for SE Asia

Nov 10, 2025

On 10 November 2025, Bio-Thera announced that it has entered into an exclusive commercialisation and licence agreement with Dr Reddy’s in relation to BAT2306, biosimilar to Novartis’ Cosentyx® (secukinumab).

Zydus Receives Tentative Approval from FDA for Olaparib Tablets

Nov 7, 2025

On 7 November 2025, Medical Dialogues reported that Zydus Lifesciences has received tentative approval from the FDA for olaparib tablets, 100 mg and 150 mg, referencing AstraZeneca/MSD’s Lynparza®.

Boan Biotech’s MAAs for Biosimilar Denosumab Accepted in UK

Nov 7, 2025

On 7 November 2025, Boan Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorisation applications (MAAs) for two denosumab injections: 60mg (BA6101; biosimilar to Amgen’s Prolia®) and 120mg (BA1102; biosimilar to Amgen’s Xgeva®).

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