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Life Sciences FDA Approval European Medicines Agency (EMA)

Goodwin

EMA Adopts Positive Opinions for Multiple Biosimilars

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In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. ...more

Goodwin

EMA Issues Positive CHMP Opinions for Fresenius Denosumab Biosimilars

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On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates....more

Goodwin

Recent Ustekinumab and Denosumab Biosimilars Deals

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On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia....more

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

Wilson Sonsini Goodrich & Rosati

2018 Life Sciences Securities Litigation Roundup

2018 Filings - Companies in the life sciences industry, including biotechnology, medical devices, and pharmaceuticals, have long been favorite targets of securities class actions, and 2018 was no exception. According to a...more

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