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Biosimilar Manufacturers to Expand Offerings in Europe and Japan

On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. ...more

GSK and Pfizer Stipulate to Dismissal of RSV Vaccines Lawsuit

On April 3, 2025, GlaxoSmithKline (GSK) and Pfizer filed a stipulation to dismiss with prejudice GSK’s litigation in the United States District Court for the District of Delaware....more

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

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

Year in Review: Top Regulatory Developments of 2024

As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024....more

GlaxoSmithKline and Northwestern Sue Moderna for Patent Infringement in Trio of Lawsuits

Last week, GlaxoSmithKline and Northwestern University filed separate lawsuits against Moderna, accusing its mRNA-based vaccines of patent infringement....more

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