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 received FDA approval for an 80...more
On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are the second and...more
On Tuesday, December 6, Regeneron filed an expedited motion to compel Mylan’s compliance with the protective order in the parties’ BPCIA litigation concerning Mylan’s proposed aflibercept biosimilar of EYLEA. Regeneron...more
Regeneron filed a complaint yesterday against Mylan in the U.S. District Court for the Northern District of West Virginia, alleging infringement of twenty-four patents under the BPCIA based on Mylan’s submission of an aBLA...more
On Thursday, July 7, 2022, California Governor Gavin Newsom announced that the most recent state budget, signed last week, includes a $100 million allotment for California to “contract to make [its] own insulin at a cheaper...more