Statute
BPCIA
102 published works
Big Molecule Watch
Amgen Files BPCIA Complaint Against Celltrion Regarding Denosumab
On May 28, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Celltrion related to its denosumab biosimilar of Amgen’s PROLIA and XGEVA. …
Big Molecule Watch
Alexion’s Preliminary Injunction Motion Denied in Eculizumab BPCIA Litigation Against Samsung Bioepis
By Emma Murray
As we previously reported, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) sued Samsung Bioepis Co. Ltd. (“Samsung”) in January 2024 in the U.S. District Court for…
Big Molecule Watch
Court Cancels Injunction Hearings In Aflibercept BPCIA Litigation; Regeneron May Seek Temporary Restraining Orders
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation. Pursuant to that…
Big Molecule Watch
Genentech and Dr. Reddy’s Settle BPCIA Rituximab Litigation
Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy’s Laboratories (“DRL”) and Fresenius Kabi. As we previously reported, Genentech, Hoffmann-La Roche, and Biogen filed a complaint…
Big Molecule Watch
Post-Trial Updates on Regeneron v. Mylan (Aflibercept) BPCIA Litigation
By Grace Truong
Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case…
Big Molecule Watch
Year in Review: Top Bioligics Regulatory Developments of 2023
By Emma Murray
As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023. FDA Approvals…
Big Molecule Watch
Year in Review: Top Legal Developments of 2023
By Yoko Bian|Natasha Daughtrey
As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of…
Big Molecule Watch
Now Available! Updated Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S., 2023-2024
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010,…
Big Molecule Watch
Alexion Sues Samsung over Proposed Eculizumab Biosimilar
Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a complaint on January 3, 2024, against Samsung Bioepis Co. Ltd. (“Samsung”) in the U.S. District Court for…
Big Molecule Watch
Breaking: Judgment in Regeneron v. Mylan (aflibercept) BPCIA Case Finding Some Claims of Asserted Patents Valid and Infringed
By Natasha Daughtrey|Joshua Weinger
As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West…