EMA accepts USV’s marketing authorisation application of proposed biosimilar Pegfilgrastim

Pegfilgrastim reduces the duration of Neutropenia and decreases the chances of infection

USV announces 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 centralised procedure.

Prashant Tewari, MD, USV said, “We are happy with the acceptance of our MAA by the EMA. USV has achieved a very significant milestone in the development programme 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.