European Medicines Agency to Review USV's Proposed Pegfilgrastim Biosimilar

USV has announced that the European Medicines Agency (EMA) has accepted for review its application for a proposed pegfilgrastim biosimilar.

Express Pharma reports that the Mumbai-based USV hopes to market the pre-filled syringe presentation of its pegfilgrastim biosimilar under the brand name Grasustek.

Prashant Tewari, MD, managing director of USV, told Express Pharma that “We are happy with the acceptance of our [application] by the EMA. USV has achieved a very significant milestone in the development program of Grasustek. We intend to provide high quality, affordable therapy options for cancer patients. We believe that Grasustek has potential life as well as cost-saving benefits for these patients.”

Filing of the application follows USV’s September 2017 announcement that it had successfully completed phase 1 and phase 3 studies on the proposed therapy. The phase 1 study compared the pharmacokinetics and pharmacodynamics of the biosimilar with the reference Neulasta at both a therapeutic dose and a low dose, and the phase 3 study followed 254 patients with breast cancer who were scheduled to undergo chemotherapy.

USV reports that, in addition to its clinical program to support submission of its application to the EMA, the company has begun planning for phase 1 development in the United States, and has held relevant meetings with the FDA. In India, USV has received approval to initiate phase 3 clinical studies for the proposed product.

USV joins fellow Indian drug maker Biocon in competing to receive the first European authorization for a pegfilgrastim biosimilar; Biocon announced in November 2017 that the EMA had accepted its resubmitted marketing authorization applications for a pegfilgrastim and a trastuzumab candidate (the recently FDA-approved Ogivri). Biocon had previously withdrawn its applications from the EMA to allow for a re-inspection of its manufacturing facility.

USV reports that is also developing biosimilars for somatropin, teriparatide, platelet-derived growth factor, filgrastim, glucagon, and epidermal growth factor.