Press Release July 06, 2016

PRESS: Tentative-Style Approvals Coming for US Biosimilars? (Scrip)

William Jay, a partner in and co-chair of Goodwin’s Appellate Litigation Practice, and Elaine Blais, head of the Litigation Department in Goodwin’s Boston office, discuss how the 180-day notice of commercial marketing applies to all biosimilar applicants. The duo also explains the latest interpretation of the US biosimilars law and how the court suggested that the FDA needs to establish a tentative-style approval approach for those products, similar to what's employed for generic drugs.

Read the full Scrip article here.