On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more
7/30/2025
/ aBLA ,
Biologics ,
Biosimilars ,
Biotechnology ,
Clinical Trials ,
Drug Pricing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Johnson & Johnson ,
License Agreements ,
Patent Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Teva Pharmaceuticals
On July 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and Accord BioPharma, Inc. (“Accord”)...more
7/24/2025
/ Amgen ,
Biosimilars ,
Case Consolidation ,
Consent Agreements ,
Intellectual Property Litigation ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Patents ,
Prescription Drugs ,
Settlement Agreements
On February 28, Amgen, Inc. (“Amgen”) filed three petitions for inter partes review, challenging the validity of all claims in three patents assigned to Bristol-Myers Squibb Co. (“BMS”). The claims of all three patents are...more
On January 23, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen and Celltrion resolving the BPCIA litigation regarding...more