Rep. Waxman Introduces Biogenerics Legislation

Legislation creating a pathway for the FDA to approve generic biologics and granting innovator companies five years of marketing exclusivity for medicines was introduced in the House. The bill, H.R. 1427, creates a pathway for both biosimilars and biogenerics and gives innovators three years of additional exclusivity for new indications, similar to provisions in the Hatch-Waxman Act for small-molecule drugs.
Drug Industry Daily