Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number of FDA-approved biosimilars to 63. Forty-one of those biosimilars have launched in the U.S. market....more
In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more
4/8/2024
/ Biologics ,
Biosimilars ,
BPCIA ,
Drug Approvals ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
USPTO
On December 7, the Biden administration announced a proposed framework for determining whether the government may exercise its march-in rights to license pharmaceutical patents to third parties if it determines that the price...more
A Tale of Two ANDAs: Jurisdiction and Venue in a Non-Traditional Sense -
Judge Gilstrap’s recent opinion in Apicore US LLC v. Beloteca, Inc., No. 2:19-CV-00077-JRG, 2019 WL 1746079 (E.D. Tex. Apr. 18, 2019), highlights...more