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
2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more
1/23/2023
/ Antitrust Provisions ,
Biosimilars ,
BPCIA ,
Competition ,
FDA Approval ,
Food and Drug Administration (FDA) ,
New Legislation ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Post-Grant Review ,
Prescription Drugs ,
Regulatory Requirements
Introduction - The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since...more
2/5/2021
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference biological product. Biosimilar applicants have a number of choices to make on the path...more
8/13/2020
/ Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
License Applications ,
Life Sciences ,
Patent Dance ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular
In February 2020, the U.S. Court of Appeals for the First Circuit found that Sanofi improperly listed U.S. Patent No. 8,556,864 (“the ’864 patent”)—which claims aspects of a drive mechanism of the Lantus® SoloSTAR® insulin...more
Federal district courts throughout the country have enacted “patent local rules” that streamline how patent cases are litigated. Here we provide a brief description of what they are, how they are applied, and some reasons...more
The Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010 to provide an abbreviated regulatory pathway for biosimilars. One of the BPCIA’s key features is a patent dispute resolution process known as the...more
This post is a part of a monthly series summarizing notable activity in patent litigation in the District of Massachusetts, including short summaries of substantive orders. Brigham & Women’s Hospital, Inc. v. Perrigo Co., No....more
As of the end of 2019, reference product sponsors (“RPSs”) have filed dozens of patent infringement cases against biosimilar manufacturers under the Biologics Price Competition and Innovation Act (“BPCIA”). The doctrine of...more
12/17/2019
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen