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European Union › European Medicines Agency (EMA)

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

Update on Recent International Biosimilar Approvals - September 2024

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Approval of Celltrion’s Ustekinumab Biosimilar in the EU:  On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA...more

Goodwin

EMA Accepts Marketing Authorization Application for Alvotech’s AVT06 (aflibercept)

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On August 15, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s biosimilar of low dose (2 mg) EYLEA (aflibercept)....more

Goodwin

EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting

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The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024....more

Goodwin

STADA and Alvotech Announce Launch of UZPROVO® in Europe

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​​​​​​​On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved...more

Goodwin

Biogen’s TOFIDENCE (tocilizumab) Approved in the EU

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​​​​​​​This week, Biogen announced that the European Commission has approved TOFIDENCE, a tocilizumab biosimilar referencing Roche’s ROACTEMRA.  TOFIDENCE was approved by the FDA in September 2023....more

Hogan Lovells

New transparency rules for EMA’s Clinical Trials Information System (CTIS) - Clinical trial data disclosure in the EU

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As of 18 June 2024, the Revised CTIS Transparency Rules as adopted by the European Medicines Agency (EMA) apply, and will impact patients, health care professionals and sponsors. Also as of 18 June, a revised version of the...more

Goodwin

European Biosimilar Regulatory Update

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In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab....more

Hogan Lovells

EMA revised its guidance on medical devices/ IVDs used in combination with medicinal products

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On 21 May 2024, the European Medicines Agency (“EMA”) published a revised version of the Questions & Answers for applicants, Marketing Authorisation Holders of medicinal products and notified bodies with respect to the...more

Goodwin

The European Parliament Adopts Position on the European Commission’s Proposal for the First Major Overhaul of the EU Medicines...

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In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more

Hogan Lovells

Clinical Trials Regulation: Transition your clinical trial now

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On 31 January 2025 the Clinical Trials Regulation will become fully applicable to all ongoing clinical trials with medicinal products in the EU. All clinical trials that have been authorized under the Clinical Trials...more

Hogan Lovells

Transition soon to the EU Clinical Trials Regulation

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Clinical trials in the European Union (EU) that were approved under the former EU Clinical Trials Directive (CTD) will soon need to transition to the current EU Clinical Trials Regulation (CTR). Sponsors and other impacted...more

Goodwin

Alvotech and STADA obtain approval in Europe for ustekinumab biosimilar, UZPRUVO

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​​​​​​​On January 10, Alvotech announced that the European Commission (EC) issued a marketing authorization to its European commercialization partner, STADA, for UZPRUVO (AVT04), a biosimilar referencing STELARA...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

Cooley LLP

EMA Adopts Revised CTIS Transparency Rules

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On 5 October 2023, the European Medicines Agency (EMA) adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The CTIS plays a...more

Hogan Lovells

European Commission steps to safeguard medicine supply in the EU

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On 24 October 2023, the European Commission (EC) adopted a set of actions in order to prevent and mitigate critical medicine shortages in the European Union (EU) this winter and beyond....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

Goodwin

Update on Recent International Biosimilar Approvals

Goodwin on

​​​​​​​Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU:  On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar...more

Hogan Lovells

AI/ML: European Medicines Agency joins the fray

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The European Medicines Agency (EMA) has finally joined the discussion on artificial intelligence (AI) and machine learning (ML), releasing a draft reflection paper on the use of these technologies throughout the medicinal...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 104

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This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide...more

Nelson Mullins Riley & Scarborough LLP

EMA Releases Official Guidance for Protecting PPD and CCI in Clinical Trial Filings within the European Economic Area (EEA)

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Version 1.1 of the European Medicines Agency's (EMA) “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical Trials...more

Goodwin

EMA Accepts MAA for Dong-A ST’s Ustekinumab Biosimilar

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On July 14, Dong-A ST announced that the European Medicines Agency accepted its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar referencing STELARA (ustekinumab). STELARA is approved for the treatment of...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 103

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. ...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

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The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more

King & Spalding

EUROPE – New Interim Guidance on Parallel EMA-HTA Body Scientific Advice

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On July 3, 2023, the European Medicines Agency (“EMA”) and the European Commission published a Guidance on Parallel EMA/HTA body Scientific Advice for the Interim Period (“Guideline”). The Guideline organizes parallel...more

Goodwin

The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years: Orphan Medicines

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We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more

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