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Sandoz

Sandoz Report the EC’s Approval of Afqlir (Biosimilar, Eylea) to Treat Neovascular Age-related Macular Degeneration (nAMD) 

Shots:  The EC has approved Afqlir(2mg vial kit & pre-filled syringe for intravitreal injection), biosimilar of Bayer’s Eylea (aflibercept), with the launch anticipated in Q4’25   Afqlir's biosimilar development program included analytical, preclinical & clinical data from the Mylight trial, establishing its equivalence in terms of efficacy & safety to the reference medicine  Aflibercept is a…

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Insights+ Key Biosimilars Events of August 2024

Insights+ Key Biosimilars Events of August 2024

Shots:      Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency       Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients       The major highlights were the US FDA’s approval of Sandoz’s Enzeevu for Treating Neovascular Age-Related…

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Sandoz

Sandoz Reports the US FDA’s Approval of Enzeevu (Biosimilar, Eylea) to Treat Neovascular Age-Related Macular Degeneration 

Shots:  The US FDA has approved Enzeevu, biosimilar version of Eylea (aflibercept), 2mg vial kit & pre-filled syringe for intravitreal injection for enhanced & sustained visual acuity among neovascular age-related macular degeneration (nAMD) patients  Approval was supported by the analytical & preclinical in vitro results plus data from Mylight trial, assessing Enzeevu (aflibercept-abzv) vs Eylea in nAMD…

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Insights+ Key Biosimilars Events of April 2024

Insights+ Key Biosimilars Events of April 2024

Shots:    Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency     Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients     During April, Samsung Bioepis and Sandoz received the EC’s Marketing Authorization approval for Pyzchiva.…

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Insights+ Key Biosimilars Events of March 2024

Insights+ Key Biosimilars Events of March 2024

Shots:   Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency    Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients    During March, Sandoz received the US FDA’s approval for Wyost & Jubbonti.…

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