In The News

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

Practices: FDA Regulatory, Intellectual Property, Intellectual Property Litigation, Life Sciences, Patent Strategy

Manufacturers of certain insulin and protein products must now follow new rules with the regulatory transition of their drugs to biological products. Life sciences IP litigation partner Filko Prugo (New York), FDA regulatory partner Kellie Combs and associate Deborah Cho (both of 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. 

The articles were based on a recent podcast hosted by Filko, Kellie and Deborah titled, Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act

Cookie Settings