As we previously reported, on September 24, 2024, the District Court for the Northern District of West Virginia denied Regeneron’s motion seeking a preliminary injunction preventing Amgen from launching its FDA-approved aflibercept biosimilar, PAVBLU (aflibercept-ayyh). A redacted version of the previously-sealed district court opinion was filed earlier this month. The…
On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI™ (ustekinumab-aauz), a biosimilar to STELARA®. FYB202/OTULFI™ is an interleukin-12 and interleukin-23 antibody and was approved for moderately to severely active Crohn’s disease,…
Approval of Accord’s Trastuzumab Biosimilar: On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. As we previously reported, HERCESSI was approved earlier…
In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. Based on alleged infringement of U.S. Patent No. 11,084,865 (“’865 patent”), Regeneron had requested a preliminary injunction that would…
On August 12, 2024, Sandoz announced that the FDA has approved ENVEEZUTM (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. ENVEEZUTM is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). According to Sandoz, the FDA also “provisionally determined that ENVEEZUTM would be interchangeable with…
The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024. Notably, the committee adopted positive opinions for the following 6 biosimilar products: Samsung Bioepis’s EKSUNBI (ustekinumab), Formycon AG’s FYMSKINA (ustekinumab), and Fresenius…
Samsung Bioepis’ PYZCHIVA On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA is approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active…
In a sealed order that issued last week, the Court has granted a preliminary injunction against Samsung Bioepis in the aflibercept BPCIA litigation brought by Regeneron. Regeneron had limited its preliminary injunction motion to a single patent, U.S. Patent No. 11,084,865 (“’865 patent”), generally directed to an ophthalmic formulation with…
FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s YESAFILI (aflibercept-jbvf) and Samsung…
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 order, Regeneron’s case against Amgen, Inc. (“Amgen”) was transferred from the Central District of California to the Northern District of…