Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On March 5, 2025, the Federal Circuit affirmed the grant of a preliminary injunction against the launch of Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42 in CAFC Case Nos. 24-2058 and 24-2147 (appealing from...more
On February 18, 2025, Alvotech and Teva announced the FDA acceptance of an aBLA for AVT06 (aflibercept), a proposed biosimilar of Regeneron’s EYLEA® (aflibercept). This aBLA joins Celltrion’s CT-P42 (aflibercept) awaiting...more
On January 15, 2025, Celltrion filed IPR2025-00456 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”), challenging claims 1-17, 19-42, 44-50 as anticipated and claims 1-50 as obvious....more
On July 8, 2024, Regeneron, Mylan, Celltrion, and Apotex jointly stipulated to the dismissal of CAFC Appeal Nos. 23-1395 and 23-1396, appealing the Final Written Decisions finding all challenged claims of U.S. Patent Nos....more
On May 17, 2024, Regeneron filed a second infringement litigation against Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42, Case No. 1:24-cv-00053 (N.D.W. Va.). The aBLA for CT-P42 was submitted to the FDA in June...more
On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”) alleging infringement of 32 patents under the...more
As we have previously reported, in November 2023 Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed complaints against Celltrion, Samsung Bioepis and Formycon (collectively, “the Defendants”) in the U.S. District Court for...more
On November 8, 2023, Regeneron Pharmaceuticals Inc. filed a BPCIA Complaint against Celltrion Inc. in the district court for the northern district of West Virginia, asking the Court to block Celltrion’s biosimilar product...more