Biosimilars

US FDA unveils long-awaited biosimilar guidance

US FDA unveils long-awaited biosimilar guidance

By Zachary Brennan

The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.

INN debate: IFPMA pushes for biosimilar label changes

Dispatches from DIA Euromeeting

INN debate: IFPMA pushes for biosimilar label changes

By Fiona BARRY

IFPMA will advocate for all biologics to have a qualifier added to their names at the WHO’s INN Consultation on April 8, the biologics giant Amgen has told BioPharma-Reporter.com.

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