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European Union › Manufacturers › Pharmaceutical Industry

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

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

Lupin Announces Licensing Deal with Sandoz for Ranibizumab Biosimilar

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On August 12, 2025, Lupin Limited (“Lupin”) announced that it has partnered with Sandoz Group AG (“Sandoz”) to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions. Ranibizumab is a recombinant...more

Barnea Jaffa Lande & Co.

European Commission Tightens Law Enforcement on Pharmaceutical Cartels

Barnea Jaffa Lande & Co. on

In July 2025, the European Competition Commission imposed a EUR 489,000 fine on Alchem International Pvt. Ltd. and its Hong Kong subsidiary for their involvement in a pharmaceutical cartel involving the active ingredient used...more

Goodwin

European Biosimilar Updates - Formycon’s Ustekinumab and Alvotech’s Cetrolizumab Pegol

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On June 26, 2025, Formycon AG (“Formycon”) announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH (“Ratiopharm”) for the semi-exclusive commercialization of its Stelara biosimilar FYB202/Fymskina...more

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

Morris James LLP

Analyzing the Impact of Recent Studies Linking Depo-Provera to Increased Meningioma Risk

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Recent scientific research has uncovered a significant association between the long-term use of Depo-Provera, a widely used injectable contraceptive, and the development of meningiomas, tumors affecting the membranes...more

A&O Shearman

New CJEU ruling on the borderline between medicinal products and medical devices: Key takeaways

A&O Shearman on

The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more

Goodwin

Recent Ustekinumab and Denosumab Biosimilars Deals

Goodwin on

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

Jones Day

Reversal of Burden of Proof Under Proposal for a New EU Product Liability Directive

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In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 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

Panelists discuss how European pharmaceutical companies can stay ahead of the game

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We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more

Hogan Lovells

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

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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

Hogan Lovells

Can sterile drug manufacturers implement EU GMP Annex 1 requirements before August?

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In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more

McDermott Will & Schulte

Intellectual Property & Health: Need to Know - France & Europe - February 2022

McDermott Will & Schulte on

UNIFIED PATENT COURT - The Unified Patent Court (UPC) should become a reality in 2022 or in the first few months of 2023. The Protocol on Provisional Application (PPA) of the Agreement on a Unified Patent Court (AUPC)...more

Proskauer - The Patent Playbook

U.S. Medical Device Manufacturers Should Take Note of New European Medical Device Regulations

Proskauer - The Patent Playbook on

The European Union has been a leader in recent years when it comes to regulatory reform intended to protect individuals’ privacy, safety, and health. As Europe leads the way, regulators in the United States often follow suit...more

Latham & Watkins LLP

EU-UK Trade and Cooperation Agreement: Implications for Life Sciences Companies

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The agreement provides guidance across several areas for the life sciences sector, though gaps remain. The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more

Skadden, Arps, Slate, Meagher & Flom LLP

Investment in Possible Future Generic Marketing Excludes Legitimate Basis for Pharma Settlement, Suggests EU Advocate General

Skadden, Arps, Slate, Meagher & Flom LLP on

In her opinion issued on June 4, 2020, Advocate General (AG) Juliane Kokott recommended that the European Court of Justice (ECJ) dismiss in its entirety the appeal by Lundbeck A/S and Lundbeck Ltd against the General Court’s...more

McDermott Will & Schulte

International News: COVID-19 Global Pandemic - May 2020

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The Legal Impact in Europe on Pharmaceutical and Medical Device Companies - The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across Europe. ...more

Hogan Lovells

EMA publishes guidance providing regulatory adaptations for MAHs in the context of COVID-19

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On 10 April 2020, the European Commission, the EMA and the European medicines regulatory network published a notice providing guidance to stakeholders regarding regulatory expectations for medicinal products for human use...more

K&L Gates LLP

COVID-19: European Commission Details Plans to Postpone EU Medical Device Regulation and European Derogation Procedure to Get...

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The European Commission (EC) has published details of its proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year. In addition, the EC proposes introducing a new procedure to address...more

Hogan Lovells

COVID-19 and emergency inventions

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As the spread of COVID-19 accelerates across the globe, everyone wants to find a way to tackle the pandemic, from Governments asking manufacturers to urgently make vital equipment to inventors creating innovative solutions. ...more

Hogan Lovells

The French "safeguard clause for medical devices” – a critical assessment

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Since 2017, the French financial regulation applicable to medical devices is gradually moving closer to the regulation governing pharmaceutical products. ...more

Hogan Lovells

Supplying medical devices without CE mark in the Netherlands during COVID-19

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In response to the COVID-19 outbreak, the Dutch Healthcare and Youth Inspectorate grants manufacturers and suppliers of medical devices the temporary opportunity to supply medical devices without a CE mark or without having...more

Robins Kaplan LLP

Financial Daily Dose 11.13.2019 | Top Story: Buffeted by Changing Consumer Demands, Dean Foods Declares Bankruptcy

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Dean Foods, the largest milk company in the U.S., has filed for bankruptcy protection, a “fresh setback to a U.S. dairy industry struggling against declining U.S. milk consumption and rising competition.”  Industry experts...more

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