News & Analysis as of

Germany Pharmaceutical Industry

Hogan Lovells

Market Access in Europe: Navigating Pricing & Reimbursement Pathways

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In Europe, the regulation of pricing and reimbursement for medicinal products is primarily governed by national policies, as EU-level regulation is limited. Our latest brochure “Market Access in Europe: Navigating Pricing &...more

Goodwin

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

Goodwin on

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

McGuireWoods LLP

Healthcare & Life Sciences Private Equity Deal Tracker: Great Point Acquires Eutecma

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Great Point Partners (GPP) has announced the acquisition of a majority stake in Eutecma. Eutecma, founded in 2008 and based in Germany, is a developer of temperature-controlled packaging solutions for pharmaceutical cold...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

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The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

White & Case LLP

CJEU: Competitors Can Sue over Data Protection Violations

White & Case LLP on

The German Federal Court of Justice (Bundesgerichtshof), tasked with resolving a conflict between two competing pharmacists, sought guidance from the Court of Justice of the European Union ("CJEU") on interpreting the General...more

Fish & Richardson

Should the Experimental Use Exception Be Broadened?

Fish & Richardson on

On June 28, 2024, the United States Patent and Trademark Office (“USPTO”) requested the public’s views on the current state of the common law experimental use exception to patent infringement and whether legislative action...more

White & Case LLP

AI implementation & data protection regulation: German authorities publish guidelines for implementing AI in compliance with the...

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The German federal and state data protection authorities published guidelines for the implementation and use of AI in compliance with the European Union's regulation of personal data ("Guidelines")....more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Goodwin

Formycon Enjoined From Manufacturing FYB202 Biosimilar of STELARA in Germany

Goodwin on

​​​​​​​As previously reported, in February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize FYB202, a ustekinumab biosimilar of Janssen’s STELARA, in key global markets after...more

Hogan Lovells

JPM2023 Trendspotting: successful early access in the EU

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As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more

Hogan Lovells

Medizinprodukte Update 2022

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Bei unserem Medizinprodukte Update Webinar im November 2022 haben die Partner:innen Dr. Jörg Schickert, Arne Thiermann und Dr. Tanja Eisenblätter, sowie Associate Dr. Benjamin Goehl den Teilnehmenden Updates zu einer Reihe...more

A&O Shearman

Pharmaceutical Antitrust

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Our Hamburg-based German antitrust team has contributed a chapter on Germany to Lexology Get The Deal Through’s global report on Pharmaceutical Antitrust. In their contribution, they provide guidance on the regulatory...more

McDermott Will & Schulte

Investing in European Healthcare - What's on the Horizon for 2022? - Regulatory and Legal Changes

Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more

A&O Shearman

Process patents – paper tigers or effective protective rights?

A&O Shearman on

When process patents are infringed, patent owners are often faced with considerable problems of providing proof of infringement. Effective enforcement is further impeded by the strict requirements set by German case law for...more

McDermott Will & Schulte

International News: Healthcare - Spotlight on the Industry - May 2021

Sovereign Wealth Fund Investment in the Global Healthcare Industry - Sovereign Wealth Funds (SWF) seek out investments that are resilient, conducive to their aims and objectives, and reasonably free from market...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 9

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In Washington: House managers finished presenting their case against former President Trump at his impeachment trial on Thursday. They argued that Trump's statements prior to and at the January 6 "Stop the Steal" rally...more

Goodwin

Lupin, Mylan Launch Etanercept Biosimilar in Germany

Goodwin on

Yesterday, Lupin announced the German launch of its etanercept biosimilar, Nepexto, for the treatment of rheumatoid arthritis, as well as all other approved indications of the reference product Enbrel®. Lupin, in association...more

Orrick, Herrington & Sutcliffe LLP

Investments in Germany under COVID 19 – Turning Crises into Opportunity

The COVID-19 pandemic has already been declared as history's gravest economic crisis. Chancellor Angela Merkel described the current situation as "the most challenging crisis we have faced since the Second World War." But...more

Hogan Lovells

CJEU: pharmaceutical companies may not distribute free samples of medicinal products to pharmacists

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On 11 June 2020, the Court of Justice of the European Union (CJEU) delivered a judgement in case C-786/18 GmbH v. Novartis Consumer Health GmbH. The judgment followed a request for a preliminary ruling by the German Federal...more

White & Case LLP

Increasing Scrutiny of Foreign Investments in the German Healthcare Sector

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The COVID-19 pandemic has changed most governments' views on the strategic relevance of the domestic healthcare sectors across the globe. Although the European Commission, and also the German government, have re-emphasized...more

Hogan Lovells

Combating COVID-19: Government powers for safeguarding supply of critical products and potential conversion of production – Italy,...

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The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more

McDermott Will & Schulte

“App on Prescription”: New Reimbursement Regime for Digital Health Applications in Germany

Health apps and other digital medical devices are making increasingly important contributions to healthcare. While in the past such medical devices were reimbursed by statutory health insurance funds on a case-by-case basis...more

Hogan Lovells

Additional German guidance on the management of clinical trials during the COVID-19 pandemic

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Further to the European Guidance on the Management of Clinical Trials during the COVID-19 pandemic, the German higher federal authorities (the Federal Institute for Medicinal Products and Medical Devices (BfArM) and...more

Hogan Lovells

Proposed measures in Germany for safeguarding supply of critical goods in the combat against COVID-19

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In the wake of combatting the COVID-19 pandemic, the German Federal Government is proposing to enable further measures on federal level. The proposal includes important measures concerning supply of medical devices,...more

McDermott Will & Schulte

COVID-19 – Legal Implications for Pharmaceutical and Medical Device Companies in Germany

The impact of Coronavirus (COVID-19) on pharmaceutical and medical device companies has been unique as, not only have these businesses had to set up emergency management systems practically overnight in order to maintain...more

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