Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar On November 14, 2025, Amgen, Inc. (“Amgen”) launched another BPCIA denosumab litigation when it filed a complaint in the U.S. District Court for the District of New Jersey against Alkem Laboratories L...

Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar

#BPCIA #Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/21/a...

Amgen Files BPCIA Complaints Against Dr. Reddy’s/Alvotech and Amneal Regarding Denosumab Biosimilars On November 6, 2025, Amgen, Inc. (Amgen) launched a new round of BPCIA denosumab litigations when it filed two cases in the U.S. District Court for the District of New Jersey, one against Dr. Reddy's ...

Amgen Files BPCIA Complaints Against Dr. Reddy’s/Alvotech and Amneal Regarding Denosumab Biosimilars

#BPCIA #Biosimilar #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/10/a...

Amgen and Samsung Bioepis Settle Denosumab BPCIA Case On September 5, 2025, the U.S. District Court for the District of New Jersey entered a Consent Order and Judgment resolving the denosumab BPCIA litigation between Amgen, Inc. (Amgen) and Samsung Bioep...

Amgen and Samsung Bioepis Settle Denosumab BPCIA Case

#BPCIA #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/06/a...

Aflibercept BPCIA Multi-District Litigation Updates The aflibercept multi-district litigation consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron Pharmaceuticals, Inc. (“Regeneron”) filing suit under the ...

Aflibercept BPCIA Multi-District Litigation Updates

#BPCIA #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/09/30/a...

Amgen Fires Back with Counterclaims in Aflibercept BPCIA Litigation As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 (“the...

Amgen Fires Back with Counterclaims in Aflibercept BPCIA Litigation

#BPCIA #Litigation #Pharmaceuticals

www.bigmoleculewatch.com/2025/09/24/a...

Would Exercising March-in Rights Lower Biologic Prices? The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds.  Many have sought to use those rights as a way to lower the cost of prescription drugs for consumers and for the federal government.

Would Exercising March-in Rights Lower Biologic Prices?

#BPCIA #Congress #BigMoleculeWatch

www.bigmoleculewatch.com/2025/09/12/w...

Sandoz and Regeneron Settle Aflibercept BPCIA Case On September 9, 2025, the District Court for the Northern District of West Virginia entered a Stipulation and Order dismissing all claims and counterclaims in view of a settlement agreement between Sa...

Sandoz and Regeneron Settle Aflibercept BPCIA Case

#BPCIA #Litigation

www.bigmoleculewatch.com/2025/09/11/s...

GENENTECH FILES FIRST PERTUZUMAB BPCIA COMPLAINT AGAINST SHANGHAI HENLIUS AND ORGANON On August 14, 2025, Genentech, Inc. and Hoffman-La Roche Inc. (together, “Genentech”) filed a BPCIA complaint in the U.S. District Court of New Jersey against Shanghai Henlius Biotech, Inc. and Shangh...

Genentech Files First Pertuzumab BPCIA Complaint Against Shanghai Henlius and Organon

#BPCIA #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/08/17/g...