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Biotechnology › Manufacturers › 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

Bergeson & Campbell, P.C.

EC Publishes Communication on Biotechnology and Biomanufacturing, Announces Targeted Actions

Bergeson & Campbell, P.C. on

The European Commission (EC) announced on March 20, 2024, that it has proposed a series of targeted actions to boost biotechnology and biomanufacturing in the European Union (EU). The EC states that its March 20, 2024,...more

Hogan Lovells

New Commission Action Plan to boost biotechnology and biomanufacturing in the EU

Hogan Lovells on

Today, 20 March 2024, the European Commission issued an important Communication aimed at boosting biotechnology and biomanufacturing in the EU. These sectors are identified as key strategic areas with ever-increasing growth...more

Bergeson & Campbell, P.C.

EuropaBio Offers Recommendations on Biomanufacturing

Bergeson & Campbell, P.C. on

On June 30, 2023, EuropaBio announced that it “set[] in stone the first European recommendations on biomanufacturing with the publication of its Biomanufacturing Policy Summit 2023 report.” On March 15, 2023, EuropaBio hosted...more

Hogan Lovells

Successful product launches across the EU, UK, and U.S.

Hogan Lovells on

We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more

McDermott Will & Schulte

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Schulte on

Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

McDermott Will & Schulte

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

McDermott Will & Schulte on

The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market” of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Hogan Lovells

European Commission adopted legal acts to improve Good Manufacturing Practices for medicinal products

Hogan Lovells on

On 15 September 2017, the European Commission adopted two legal acts intended to update good manufacturing practice (“GMP”) requirements for investigational and authorised medicinal products in the EU. The purpose of these...more

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