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European Union › Prescription Drugs

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

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

A&O Shearman

European Commission fines Alchem in first cartel case involving a pharmaceutical API

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On 4 July 2025, the EC fined Alchem and its subsidiary EUR 489,000 for their role in a long-running cartel concerning the active pharmaceutical ingredient SNBB, used in the production of Buscopan and its generics. This marks...more

Goodwin

Lupin and Zentiva Reach Agreement to Commercialize Certolizumab Pegol Biosimilar

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On July 9, 2025, Lupin Limited and Zentiva Group announced a license and supply agreement to commercialize Lupin’s biosimilar of Certolizumab Pegol across multiple global markets. ...more

Hogan Lovells

Medicines shortages under the EU pharma law package

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The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

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

Goodwin

Sandoz Launches PYZCHIVA® (Ustekinumab) Autoinjector in Europe

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On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.”...more

A&O Shearman

UK will permanently retain its UK+ exhaustion regime to allow continued supply of medicines into the UK

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The government has published its response to the consultation on the exhaustion regime for IP rights. The overall conclusion is that the UK will permanently maintain its UK+ IP exhaustion regime, the bespoke (and...more

McDermott Will & Emery

Navigating Political Waves and Policy Shifts - European Health & Life Sciences Symposium 2025

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In April, McDermott gathered more than 100 health and life sciences innovators, investors, business leaders and advisers in Paris for our annual European Health & Life Sciences symposium. With such an esteemed crowd available...more

Goodwin

EMA Issues Positive CHMP Opinions for Biocon’s Denosumab Biosimilars

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Last week, Biocon Biologics Ltd (“BBL”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Biocon’s two denosumab biosimilar candidates....more

Goodwin

CuraTeQ Biologics’ Trastuzumab biosimilar Receives Positive Opinion in Europe

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This week, CuraTeQ Biologics (a wholly owned step-down subsidiary of Aurobindo Pharma Limited) announced that its trastuzumab biosimilar, DAZUBLYS, has received a positive opinion from the European Medicines Agency Committee...more

Goodwin

Accord Receives Positive EMA Opinion for Two Denosumab Biosimilars

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On April 2, 2025, Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for two denosumab biosimilars: OSVYRTI and JUBEREQ. OSVYRTI is indicated for the...more

Hogan Lovells

Early benefit assessment of medicinal products in Germany – first adaptions to AMNOG implementing the EU HTA Regulation

Hogan Lovells on

First adaption of German AMNOG to the EU HTA Regulation: With the German Federal Ministry of Health's recent adoption of the respective ordinance in Germany (AMNutzenV), the German legislator took a first step to integrate...more

Goodwin

European Commission Approves Celltrion’s AVTOZMA (CT-P47)

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​​​​​​​On February 23, 2025, Celltrion announced that the European Commission (“EC”) approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche’s ROACTEMRA®....more

Goodwin

Dr. Reddy’s Secures License from Henlius to Market Daratumumab Biosimilar in the U.S. and Europe

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On February 6, 2025, Dr, Reddy’s Laboratories SA (“Dr. Reddy’s”) announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (“Henlius”) for the development and commercialization of Henlius’s...more

Goodwin

EU Biosimilar Regulatory and Launch Updates

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CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending...more

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

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated January 13, 2025

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Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more

Goodwin

EMA’s CHMP Recommends Approval of Six New Biosimilars

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The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars....more

Goodwin

European Commission Approves Samsung Bioepis and Biogen’s Aflibercept Biosimilar

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​​​​​​​On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ.  ...more

Goodwin

Celltrion Launches STEQEYMA (ustekinumab) in Germany and the Netherlands

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As we previously reported, this August the European Commission granted approval for Celltrion’s STELARA biosimilar, STEQEYMA. Earlier this month, Celltrion launched STEQEYMA in both Germany and the Netherlands....more

Goodwin

EMA Accepts Marketing Authorization Application for Alvotech’s AVT05 (golimumab)

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​​​​​​​On November 4, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s biosimilar to Simponi® (golimumab), for the...more

Goodwin

Bio-Thera and Gedeon Richter Reach Exclusive Commercialization Agreement for Ustekinumab Biosimilar

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On October 9, 2024, Bio-Thera Solutions and Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to STELARA (ustekinumab). ...more

McDermott Will & Emery

New Pharmaceutical Industry Standards Apply to the Promotion of Medicines in the United Kingdom: ABPI Code 2024 and the PMCPA...

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Pharmaceutical companies promoting prescription-only medicines to health professionals and other relevant decision makers in the UK must now adhere to revised industry standards that came into operation from 1 October 2024...more

Goodwin

Teva’s Denosumab Biosimilar Candidate is Accepted for Review by FDA and EMA

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On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a...more

Goodwin

Fresenius and Formycon Receive EC and FDA Approval of Ustekinumab Biosimilar

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On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI™...more

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