Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging…
Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging…
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…
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and…
Late last month, a Patent Trial and Appeal Board (“PTAB”) panel instituted two petitions that were filed separately by Celltrion and Biocon for inter partes review (“IPR”) of Regeneron’s…
Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price…
Regeneron files ex parte application for a preliminary injunction schedule in case against Amgen On Friday, January 20, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed an ex…
Celltrion Submits BLA for Tocilizumab Biosimilar On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab…
On January 17, 2024, Celltrion announced the U.S. launch of a new, 80 mg/0.8 ml dosage strength of its HUMIRA® biosimilar, YUFLYMA® (adalimumab-aaty). As we previously reported, Celltrion…
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…
Regeneron Filed Complaint Against Amgen in C.D. Cal. Over ABP 938 Biosimilar to EYLEA On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S….