On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson’s STELERA® (ustekinumab). The product was approved as a subcutaneous injection for the treatment of adult and pediatric patients 6 years and older with moderate to severe plaque psoriasis and for active psoriatic…
As we previously reported, the U.S. Department of Justice (“DOJ”) filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts regarding Regeneron’s sales of Eylea in 2020. The DOJ recently announced that it has filed another False Claims Act complaint against Regeneron Pharmaceuticals, alleging that…
As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’ proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. On December 27, 2023, the court entered judgment in the…
On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation. As we previously reported, Fresenius Kabi received FDA approval for both intravenous and subcutaneous formulations on March 5, 2024, making TYENNE the first tocilizumab biosimilar approved in both formulations. TYENNE is…
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 in the U.S. District Court for the District of New Jersey in November 2023, alleging that DRL’s proposed rituximab biosimilar…
As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation, and to transfer its case against Amgen, Inc. (“Amgen”) to the Northern District of West Virginia under 28 U.S.C. § 1407. The litigation consists of six…
On April 4, 2024, Bristol Myers Squibb (“BMS”) and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI),…
On April 1, 2024, the Federal Circuit released its opinion in Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., affirming the district court’s finding that certain claims were not indefinite and remanding to the district court to reevaluate its obviousness decision. The Federal Circuit’s analysis provides…
On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. ENHERTU, which is now FDA-approved for five indications, is a…
As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274 by Sarepta’s gene therapy product, ELEVIDYS (delandistrogene moxeparvovec-rokl). On September 19,…