Kearney Leaderboard

biologic products

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 Late late week, the FDA published draft guidance recommending that reference biologic products and biosimilars have nonproprietary names that share a core drug substance name and an FDA-designated suffix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

State biosimilars legislation hailed by GPhA

WASHINGTON — The Generic Pharmaceutical Association (GPhA) and its recently formed Biosimilars Council have praised the enactment of new legislation in five states to allow automatic substitution for Food and Drug Administration-approved interchangeable biologic products. Bills in Colorado (SB 71), Georgia (SB 51), Tennessee (SB 984), Utah (HB 279) and Washington (SB 5935) reflect core

Pharmaceutical companies form Biosimilars Forum

WASHINGTON — A coalition of 11 biopharmaceutical companies has formed the Biosimilars Forum, described as the first nonprofit organization for expanding patient access to biosimilars in the United States. The group said Tuesday that its founding members represent the majority of companies with the most significant U.S. biosimilars development portfolios, including Actavis, Amgen, Boehringer Ingelheim,