As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year: USPTO Outlines New Initiatives Regarding Drug Pricing In July, we reported that Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published a letter summarizing several…
Luye Pharma Group announced last week that China’s National Medical Products Administration has approved a marketing launch of BOYOBEI® for treatment of postmenopausal women with osteoporosis at high risk of fractures. Luye Pharma Group, in conjunction with its subsidiary Boan Biotech, is now the first company in the world to receive…
The Big Molecule Watch is monitoring Phase III clinical trials involving denosumab biosimilars. Here we report on the results of two recently completed studies. On June 30, 2022, a study was published showing that the efficacy of AryoGen Pharmed’s biosimilar denosumab candidate, ARYLIA, is noninferior to Amgen’s PROLIA for the…
Organon announced yesterday that it has entered into an agreement with Henlius, whereby Organon will license commercialization rights for biosimilar candidates referencing PERJETA® (pertuzumab) and PROLIA®/XGEVA® (denosumab). According to the press release, Henlius independently developed both biosimilar products. Organon will acquire exclusive global commercialization rights except for China. The agreement…
Over the past two weeks, there have been a number of announced clinical studies and updates from biosimilar developers around the world. On November 9, Shanghai based Henlius Biotech, Inc. announced the start of its Phase I clinical trial of HLX14, the company’s biosimilar to Prolia® (denosumab). According to the…
Shanghai Henlius Biotech (Henlius) recently announced that China’s National Medical Products Administration (NMPA) has approved an investigation new drug (IND) application[1] of HLX14, a denosumab biosimilar. Denosumab is a recombinant humanized anti-RANKL monoclonal antibody for injection that is approved for the treatment of postmenopausal women with osteoporosis with a high…
In recent weeks, several drug makers announced collaborations for the development, manufacture, and/or commercialization of a variety of biosimilars or follow-on biologics. Below are some highlights: On September 3, 2019, Polpharma Biologics and Sandoz announced that they have entered into a global commercialization agreement in connection with Polpharma’s proposed biosimilar…
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…
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…
We are continuing to see regulatory and commercial activity in the biologics space with companies pursuing new indications and approvals. Amgen announced today both the submission of a supplemental BLA to the FDA and an application for a variation to the marketing authorization to the EMA for XGEVA (denosumab). With these applications,…