In Pink Sheet Articles, Life Sciences Attorneys Examine New FDA Provisions for Biosimilars

In The News
March 25, 2020

Manufacturers of certain insulin and protein products must now follow new rules with the regulatory transition of their drugs to biological products. FDA regulatory partner Kellie Combs (Washington, D.C.) were quoted in three separate Pink Sheet articles on the anticipated impact that the FDA transition provision will have on regulatory exclusivity, patent litigation, and the biologics and biosimilars market.