Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
8/12/2025
/ AbbVie ,
Amgen ,
Biologics ,
Biosimilars ,
Boehringer ,
BPCIA ,
Celltrion ,
Center for Drug Evaluation and Research (CDER) ,
Coherus ,
Mylan Pharmaceuticals ,
Non-Practicing Entities ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron ,
Samsung Bioepis ,
Sandoz ,
Sponsors
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
4/18/2025
/ Amgen ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sanofi
Earlier today, the Supreme Court issued a unanimous decision in Amgen v. Sanofi, construing the statutory enablement requirement.
The case concerns antibodies that help reduce levels of LDL cholesterol....more