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
On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz’s ENVEEZU (aflibercept-abzv)....more
Biogen seeks a preliminary injunction in its BPCIA case against Sandoz related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab). On October 20, 2022, the Court issued a sealed order on the parties’ joint...more
On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics. Biogen’s complaint is filed under seal. Based on the list of 28 asserted patents, the case appears to...more
Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic...more
8/30/2022
/ Biologics ,
Biosimilars ,
Celltrion ,
European Commission ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Marketing Authorization Application ,
Pharmaceutical Industry ,
Regulatory Approval ,
Sandoz ,
Teva Pharmaceuticals