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European Union › BPCIA › FDA Approval

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 -
Venable LLP

FDA Approves Second Prolia® / Xgeva® (denosumab) Interchangeable Biosimilars: Samsung Bioepis’s Ospomyv™ / Xbryk™

Venable LLP on

On February 13, 2025, the FDA approved Samsung Bioepis’s Ospomyv™ / Xbryk™ (denosumab-dssb) as the second interchangeable biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Continues to Approve Biosimilars

McDonnell Boehnen Hulbert & Berghoff LLP on

The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has...more

Patterson Belknap Webb & Tyler LLP

Ten Years of Biosimilars in Europe

Patterson Belknap Webb & Tyler LLP on

This fall marks the tenth anniversary of the effective date of the European Medicines Agency’s Guideline on Similar Biological Medicinal Products. As this blog noted previously, the EU’s biosimilar pathway both preceded the...more

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