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Manufacturers Regulatory Authority European Union

Goodwin

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

Goodwin on

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

BCLP

Key Insights on the EU Cyber Resilience Act - What Businesses Need to Know

BCLP on

The Cyber Resilience Act (CRA) is a groundbreaking piece of legislation designed to enhance the cybersecurity of digital products and services made available in the EU. Published last week in the Official Journal of the...more

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