FDA Biosimilar Action Plan — Lanton Law Blog

New Rule: Transition to BLA Pathway Is Complete

As of today, March 23, 2020, the life sciences industry completes “the transition.” New categories of biologics will now be licensed via the biologics approval pathway under the Biologics Price Competition and Innovation Act (BPCIA). This transition occurs 10 years after the 2009 enactment of the BPCIA.

CMS, Congress, life sciences, pharmaceuticals, pharmacyRon LantonMarch 23, 2020biosimilars, biologics, FDA Biosimilar Action Plan, BLA, FDA, the transition, BPCIA

Pharmacy Times Recaps Lanton Law's NASP Presentation on the FDA Biosimilars Action Plan

During the 2019 National Association of Specialty Pharmacy Annual Meeting and Expo, Ron Lanton III, Esq, reviewed the FDA Biosimilars Action Plan, its implications for the biosimilar marketplace, recent legislation set to influence the biosimilar pathway and drug accessibility, and the future of the biosimilar market.

biologics, Biosimilars, healthcare, life sciences, pharmaceuticals, pharmacy, home infusionRon LantonDecember 27, 2019FDA, biosimilars, FDA Biosimilar Action Plan