On July 31, the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (“Action Plan”) created with the Food and Drug Administration (FDA) to “allow the importation of certain prescription drugs originally intended for foreign markets,” particularly Canada. According to the HHS Secretary Alex Azar, “[the…
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…
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…
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…
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…
On June 28, 2019, Samsung Bioepis and Genentech filed a joint stipulation of dismissal of their BPCIA patent litigation concerning ONTRUZANT (trastuzumab-dttb), Samsung Bioepis’s biosimilar of HERCEPTIN that received FDA-approval earlier this year. According to the stipulation, the parties “have entered into a settlement agreement, and mutually agree to voluntarily dismiss…
Below are some highlights of recent news in biosimilar and follow-on biologic development: On June 14, Sandoz announced positive clinical study data regarding HYRIMOZ, its biosimilar of HUMIRA (adalimumab). According to Sandoz’s press release, data from a 48-week phase 3 clinical study demonstrated that switching from HUMIRA to HYRIMOZ provides…
Today, June 13, 2019, the U.S. FDA approved Amgen’s aBLA for KANJINTI (trastuzumab-anns), a biosimilar of Genentech’s HERCEPTIN. According to its approved package insert, KANJINTI, like its reference product, is indicated for the treatment of HER2 overexpressing breast cancer and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction…
A recent analysis reveals that prescription drug prices continue to increase — even for drugs with FDA-approved therapeutic equivalents or biosimilar products. Dr. Nathan Wineinger evaluated the change in prescription drug prices over a 6-year period for the 49 top-selling brand-name medications in the United States. The price of 48…
On May 9, 2019, U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) announced that they had introduced the Affordable Prescriptions for Patients Act. According to the sponsors’ press release, the bill is designed to prevent “product hopping and patent thicketing within the Federal Trade Commission (FTC) Act.” In the…