Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)

Shots: The US FDA has accepted the resubmitted BLA of ONS-5010 (bevacizumab-vikg) for the treatment of wAMD, considering a Class 1 review & granting a PDUFA goal date Dec 31, 2025; if approved, it will be branded Lytenava ONS-5010 (intravitreal) is an ophthalmic bevacizumab formulation that binds all VEGF isoforms to block VEGF interaction with…

ByRidhi Rastogi3 days ago

Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea)

Shots: The EC has approved Mynzepli (AVT06), a biosimilar version of Eylea (aflibercept) for all indications of the reference product in all 30 EEA states; AVT06’s Dossiers are under review in multiple regions incl. the US & Japan Approval was based on extensive analytical, non-clinical & clinical data incl. a confirmatory study assessing Mynzepli vs…

ByRidhi RastogiAugust 21, 2025

The US FDA Approves Biocon Biologics’ Jobevne (Biosimilar, Avastin)

Shots: The US FDA has approved Jobevne, a biosimilar version of Avastin (bevacizumab) for IV administration Approval was based on extensive data showing Jobevne is similar to Avastin in PK, safety, efficacy, structure, & function across clinical & analytical studies Jobevne (VEGF inhibitor) is marketed under the brand name Abevmy in the EU & Canada,…

ByRidhi RastogiApril 10, 2025

Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)

Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea)

The US FDA Approves Biocon Biologics’ Jobevne (Biosimilar, Avastin)

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