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European Union › Biosimilars › Manufacturers

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Goodwin

Biosimilar Manufacturers to Expand Offerings in Europe and Japan

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On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. ...more

Goodwin

Recent Ustekinumab and Denosumab Biosimilars Deals

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On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia....more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Hogan Lovells

EU SPC Manufacturing Waiver Now in Force

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The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469).  The Waiver has been introduced with the stated aim of putting EU generic and...more

Goodwin

EU Parliament Takes Steps to Increase Manufacture and Export of European Generics and Biosimilars During Protected Period

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The Committee on Internal Market and Consumer Protection of the European Parliament has adopted its report on the “Single Market Strategy” – a strategy that aims to consolidate industries in European countries under one...more

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