NT_1170x120_1-11-18

Edith Rosato

FDA proposes suffix for biosimilar product names

FDA proposes suffix for biosimilar product names

WASHINGTON — Early feedback on the Food and Drug Administration’s proposal on naming conventions for biosimilars shows a mixed response. Late late week, the FDA published draft guidance recommending that reference biologic products and biosimilars have nonproprietary names that share a core drug substance name and an FDA-designated suffix unique for each product. For interchangeable