As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big...more
1/15/2025
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Celltrion ,
FDA Approval ,
Inflation Reduction Act (IRA) ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. ...more
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation....more
As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial...more
5/26/2023
/ Amgen ,
Biosimilars ,
BPCIA ,
Mylan Pharmaceuticals ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron ,
Right of Access ,
Sealed Records
On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen’s RIABNI (rituximab-arrx), a biosimilar to Genentech’s RITUXAN®, in combination with methotrexate for treatment of moderate to...more