TRP_1170x120_3-8-19

biologic drugs

Pharmacy groups advocate USP standards for biologics

Pharmacy groups advocate USP standards for biologics

WASHINGTON — A coalition of pharmacy industry organizations has asked congressional leaders to weigh proposals that would free certain biologic drugs from adherence to U.S. Pharmacopeia (USP) standards. This week, the American Pharmacists Association (APhA) and eight other groups sent a letter to the chairman and ranking members of key House and Senate committees expressing

N.J. governor signs biosimilars legislation

N.J. governor signs biosimilars legislation

WASHINGTON — New Jersey Gov. Chris Christie has approved legislation to create a pathway for the substitution of interchangeable biologic drugs, drawing praise from the Biotechnology Industry Organization (BIO) and BioNJ, a state biotechnology organization. Christie signed Assembly Bill 2477 into law on Monday, following unanimous passage in the New Jersey Senate and Assembly earlier

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 Late late week, the FDA published draft guidance recommending that reference biologic products and biosimilars have nonproprietary names that share a core drug substance name and an FDA-designated suffix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