Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national...more
3/7/2025
/ Biologics ,
Biosimilars ,
Biotechnology ,
BPCIA ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Life Sciences ,
Paris Convention ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech,...more
1/2/2025
/ Amgen ,
Biogen Idec ,
Biosimilars ,
BPCIA ,
Genentech ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron
As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab...more
5/16/2024
/ Biologics ,
Biosimilars ,
Biotechnology ,
BPCIA ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On December 9, 2022, Biogen announced that the FDA has accepted for review an aBLA for BIIB800, Biogen’s tocilizumab biosimilar candidate. BIIB800 references Genetech’s ACTEMRA product, which is an anti-interleukin-6...more
Yesterday, Amneal Pharmaceuticals, Inc. announced the launch of its first biosimilar in the United States: ALYMSYS (bevacizumab-maly), a biosimilar referencing Genentech’s AVASTIN product. ALYMSYS is a vascular...more
On July 26, Prestige Biopharma Limited (“Prestige”) announced a partnership with Intas Pharmaceuticals Limited (“Intas”) and its affiliate Accord Healthcare to commercialize Prestige’s bevacizumab, HD204, a proposed...more
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab). Humira®...more