On April 29th, the district court for the district of New Jersey (J. Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program. BMS and Janssen alleged that the Drug Price Negotiation Program (i) effects a taking of…
FDA Updates Draft Guidance on Promotional Communications of Prescription Biologics and Biosimilars On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions…
On April 29, 2024, Accord BioPharma, Inc. announced that the U.S. Food and Drug Administration (FDA) approved HERCESSI (trastuzumab-strf). HERCESSI is a biosimilar to HERCEPTIN (trastuzumab) and is indicated for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric…
On April 22, 2024, the PTAB issued final written decisions in IPR2023-00070 and IPR2023-00074, filed by Bluebird Bio on two patents related to recombinant lentiviral vectors — U.S. Patent Nos. 7,541,179 and 8,058,061, owned by Sloan Kettering Institute for Cancer Research. The PTAB ruled that all challenged claims of the…
On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen Netherlands B.V.’s biosimilar TOFIDENCE (tocilizumab), for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and coronavirus disease…
Late last week, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC filed suit in the District of Delaware alleging that Pfizer, Pharmacia & Upjohn, BioNtech SE, BioNtech Manufacturing GMBH, and BioNTech US, Inc. infringe five U.S. patents directed to mRNA vaccine technology. The Patents-In-Suit are U.S. Patent Nos. 11,638,693; 11,638,694; 11,666,534; 11,766,401;…
We previously reported on the litigation brought by ModernaTX, Inc. and Moderna US, Inc. (collectively, “Moderna”) against BioNTech SE, BioNTech Manufacturing GmbH, BioNTech US Inc. (collectively, “BioNTech”), and Pfizer Inc. (“Pfizer”) related to Moderna’s mRNA technology and the subsequent inter partes review (IPR) petitions filed by BioNTech and Pfizer. Those…
On April 23, 2024, Alvotech announced “positive topline results from a confirmatory clinical study for AVT05,” Alvotech’s proposed golimumab biosimilar to Janssen Biotech, Inc.’s SIMPONI(R) and SIMPONI ARIA(R). According to Alvotech, the confirmatory clinical study (NCT05842213) was a randomized, double-blind, two-arm, multicenter clinical study designed to investigate the therapeutic equivalency…
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…