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Formycon/Fresenius Kabi and Samsung Bioepis Settlements with J&J and Janssen Biotech regarding Ustekinumab

LexBlog IP

On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed by J&J. Economic terms of the settlement were not disclosed in the press release.

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Celltrion Stelara (Ustekinumab) Settlement With J&J

LexBlog IP

market on March 7, 2025, if approved by FDA. J&J also recently filed a confidential settlement and license agreement to terminate a Samsung Bioepis challenge to all claims of U.S.

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Health Data: European Commission Proposes new Rules on Access and Use

LexBlog IP

The European Commission expressed its hope that the provisions of the regulation will enter into force across all EU member states in 2025. These include, among others, the use to take decisions that may be detrimental to a natural person or the use for advertising or marketing.

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Biosimilar Regulatory Updates

LexBlog IP

In October 2023, Accord settled with Janssen Biotech under confidential terms that would allow Accord to launch its proposed ustekinumab biosimilar no later than May 15, 2025, pending FDA approval. Accord, a global subsidiary of Intas Pharmaceuticals, will be responsible for U.S. commercialization.

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Tuesday Tiddlywinks

The IPKat

Paid Internship at Ericson: Economist in the Intellectual Property Rights (IPR) Policy Research Team (m/f/d). Topics to be covered include: how will the EU IP Action Plan impact the Single Market? AlgoSoc International Conference 2025: 10 April 2025. 2025 Annual Meeting, 17 May 2025, San Diego, California, USA.

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Biosimilars 2020 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

At the same time, market uptake of biosimilars in the United States continued to increase, suggesting that there is room for expansion of biosimilars in the U.S. In addition, fewer new biosimilars entered the market this past year, with five biosimilar launches in 2020 as compared to seven in 2019. Yet biosimilars of anti-TNF?