TRP_1170x120_3-8-19

Bertrand Liang

GPhA council works to promote biosimilars

GPhA council works to promote biosimilars

Biosimilars offer tremendous promise for millions of Americans suffering from cancer, rheumatoid arthritis or other diseases, offering lower-cost and highly effective alternatives to costly reference product drugs, also known as biologics. Biosimilars have been approved and prescribed effectively for close to a decade in nations across Europe and in Australia, offering patients increased access to

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 Late late week, the FDA published draft guidance recommending that reference biologic products and biosimilars have nonproprietary names that share a core drug substance name and an FDA-designated suffix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