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EMA accepts USV’s marketing authorization application for proposed biosimilar Pegfilgrastim

Our Bureau, Mumbai
Thursday, December 7, 2017, 16:20 Hrs  [IST]

USV announced regulatory submission of proposed biosimilar Pegfilgrastim (Grasustek) and acceptance for review by European Medicines Agency (EMA). USV had earlier announced the completion of the pivotal phase III and phase I studies for Grasustek. Subsequent to this, the MAA for Grasustek was submitted through the centralized procedure.

Prashant Tewari, managing director, USV Ltd. said – “We are extremely happy with the acceptance of our MAA 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. ”

Pegfilgrastim reduces the duration of Neutropenia (a low count of neutrophils, a type of white blood cells) and therefore decrease the chances of infection. It is known to reduce the incidence of febrile neutropenia in adult cancer patients treated with cytotoxic chemotherapy for malignancy (with exception of chronic myeloid leukemia and myelodysplastic syndromes)

USV Pegfilgrastim (Grasustek) is a proposed biosimilar to Amgen’s Neulasta and is wholly developed by USV.

USV is a 55 year old leading healthcare company in India. The product portfolio comprises of APIs, solid orals, injectables, ophthalmics, biosimilars, peptides. USV markets products globally to regulated markets such as US, Europe, Japan, Korea, Australia and a number of rest of the world countries. In India USV has been recognised for leadership in the oral anti-diabetic market and cardiovascular diseases segment. It also has a significant presence in the areas of nutritional supplements, dermatology, and gynaecology. it has access to generic markets through Indicus LLC in USA, USV North America & USV Europe.


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