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Prescription Drugs Biotechnology European Commission

Goodwin

European Biosimilar Updates - Alvotech/Advanz’s MYNZEPLI Approval and Bio-Thera/STADA Tocilizumab Alliance

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On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. ...more

Goodwin

European Commission Approves Moderna’s Updated COVID-19 Vaccine

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On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna’s COVID-19 vaccine Spikevax®.  The updated vaccine targets the LP.8.1 variant of...more

Goodwin

Biocon Regulatory Approval Updates in the U.S. and Europe: Insulin Aspart and Denosumab

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On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Growing Competition for the World’s Most Profitable Drug as Multiple New Adalimumab Biosimilars Launch

During the first quarter of 2021, multiple companies launched adalimumab biosimilars as a growing number of biosimilar players marketed their versions of the world’s most profitable drug, Humira®, which had sales of about $20...more

Goodwin

Global Biosimilar Update

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The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or...more

American Conference Institute (ACI)

[Event] Pharmaceutical Patent Term Extensions – The Only Specialized Forum on SPCs and Patent Protection in Europe and Around the...

This year’s C5’s Pharma Patent Term Extensions Forum arrives at a critical time for the pharmaceutical industry. Overarching developments from the Teva U.K. decision (C-121/17) to the SPC Manufacturing Waiver and the most...more

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