Fulphia , a pegfilgrastim biosimilar, is launched in Canada. Mylan + BGP Pharma ULC + Biocon

Mylan and Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country. Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy. Fulphila (MYL?1401H) has been approved by Health Canada, the country’s drug regulator, to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. Health Canada’s approval of Fulphila was based on a comprehensive package of analytical, non-clinical and clinical data, which confirmed that the product is highly similar to the originator biological, Amgen’s Neulasta, and that there were no clinically meaningful differences in terms of safety and efficacy exist.