Regulatory Update – 7/22/2019

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 over a period of 78 weeks.

On July 19th, Samsung Bioepis announced that the European Medicines Agency will review SB8, Samsung Bioepis’s biosimilar candidate referencing AVASTIN (bevacizumab). If approved, SB8 will be commercialized in Europe by Merck Sharp & Dohme, known as Merck & Co. in the United States and Canada.

On July 16th, Outlook Therapeutics announced that it had dosed the first patient in a Phase 3 clinical trial regarding ONS-5010, its ophthalmic bevacizumab product candidate for the treatment of wet age related macular degeneration (wet AMD) and other retina diseases.  This is the second of two required adequate and well controlled Phase 3 clinical trials evaluating ONS-5010 against ranibizumab (LUCENTIS) for wet AMD. The study is expected to enroll a total of at least 220 patients over the course of 11 months.

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