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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

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

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

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 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. ...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

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

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

A&O Shearman

European Commission sanctions first ever pharmaceuticals cartel and scores victory in pay-for-delay appeal

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The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more

Goodwin

UK’s Medicines Regulator Announces Guidance on the New International Recognition Procedure for the Approval of New Medicines from...

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Earlier this year, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that a new International Recognition Procedure (IRP) will be put in place for the approval of new...more

King & Spalding

Goodbye Reboxing! European Court of Justice Restricts Parallel Imports of Medicines

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On November 17, 2022, the Court of Justice of the European Union (CJEU) found in its latest principal judgment (Novartis v. Abacus, case file C-147/20) that the reboxing of parallel imported medicines in the European Union...more

Goodwin

STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in Europe

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On November 11, 2022, STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (“Xbrane”) announced that the European Commission has granted a marketing authorization for XIMLUCI (ranibizumab), a biosimilar to Genentech’s...more

Jones Day

Covid-19 Key EU Developments, Policy & Regulatory Update No. 81

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COMPETITION & STATE AID - Competition- European Commission ramps up home searches of employees of companies suspected of potential competition breaches - On 5 April 2022, Maria Jaspers (Director of Cartel Directorate, DG...more

Jones Day

Covid-19 Key EU Developments, Policy & Regulatory Update No. 77

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COMPETITION & STATE AID - State Aid- European Commission publishes Annual Single Market Report 2022 - On 22 February 2022, the European Commission published the Annual Single Market Report 2022, which sets out, in...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 66

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Competition - European Commission comments on the future of competition policy - On 29 October 2021, Executive Vice-President and Competition Commissioner Margrethe Vestager provided remarks on the future of competition...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 64

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European Commission adopts Communication on Energy Prices to tackle exceptional rise in energy prices - On 13 October 2021, the Commission adopted a Communication on Tackling Rising Energy Prices: a Toolbox for Action and...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 63

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State Aid - European Commission consults on proposed amendments to General Block Exemption Regulation - On 6 October 2021, the Commission opened its consultation with Member States and interested parties to comment on...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 61

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European Commission releases State of the Union 2021 report, including on COVID-related State aid - On 15 September 2021, the Commission published the State of the Union 2021 report on the Commission’s work and...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 58

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This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 57

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This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS...more

Goodwin

Global Biosimilar Update

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The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or...more

King & Spalding

European Commission Proposal Would Make It Harder for Innovator Companies to Launch Friendly Duplicates (Biosimilars)

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The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical...more

Jones Day

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

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The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more

Hogan Lovells

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

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On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

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