On July 23, 2019, Amgen sued Tanvex BioPharma USA, Inc. and two of its affiliates in the Southern District of California alleging infringement of U.S. Patent No. 9,856,287 under the BPCIA based on Tanvex’s submission of an aBLA for a biosimilar of NEUPOGEN (filgrastim). As relief, Amgen’s complaint requests, among…
Earlier this week, the U.S. FDA approved Samsung Bioepis’s HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HADLIMA is the fourth adalimumab biosimilar to receive approval in the U.S. According to…
As we previously reported, last week the U.S. District Court for the District of Delaware denied Genentech’s motion for a preliminary injunction against Amgen in the BPCIA litigation concerning Amgen’s Kanjinti (trastuzumab-anns). A redacted version of the court’s opinion has now been posted to the public docket. As set forth…
Sandoz announced today that it has enrolled the first patient in the ROSALIA Integrated Phase I/III study for its proposed biosimilar denosumab to confirm matching efficacy, safety and immunogenicity with the reference medicine, Amgen’s PROLIA in patients with postmenopausal osteoporosis. The trial aims to study approximately 520 menopausal patients with osteoporosis…
Earlier this week, Alvotech announced that it has completed enrollment of its Phase III study of AVT02, its proposed biosimilar of Humira® (adalimumab). The study has enrolled 407 patients with moderate-to-severe chronic plaque psoriasis and will occur across approximately 30 sites in Europe “to compare AVT02 and Humira® in terms…
As we previously reported, on July 10, 2019, Genentech filed motions for a temporary restraining order and preliminary injunction against Amgen in the Genentech v. Amgen BPCIA litigation related to Amgen’s trastuzumab biosimilar KANJINTI™ (trastuzumab-anns). Yesterday, the District Court denied Genentech’s motions and lifted the standstill order given during the…
In May, the U.S. Department of Health and Human Services (“HHS”) finalized a new regulation requiring pharmaceutical companies to disclose the list price of a drug in any television advertisements. This regulation, titled “Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency” (also known as the Wholesale Acquisition Cost,…
On the morning of July 11, Chief Judge Prost, Judge Linn, and Judge Hughes heard oral argument in Genentech v. Hospira, Case No. 18-1959. Genentech appealed from a final written decision by the Patent Trial and Appeal Board (PTAB) on IPR2016-01771 that invalidated U.S. Patent No. 7,622,115 (the ’115 patent)…
Last night, Genentech filed a motion for a temporary restraining order and a motion for a preliminary injunction against Amgen in the Genentech v. Amgen BPCIA litigation related to Amgen’s trastuzumab biosimilar KANJINTI (trastuzumab-anns). Genentech’s motion papers were filed under seal, and Amgen’s responsive papers on the preliminary injunction motion…
Below are some highlights of recent news in biosimilar and follow-on biologic development: Prestige BioPharma On July 2, Prestige BioPharma (Prestige) licensed the rights to Tuznue, its trastuzumab biosimilar of Roche’s Herceptin, to Mundipharma in selected European markets. The European Medicines Agency (EMA) recently accepted a Marketing Authorisation Application for…