The 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 neulasta and no clinically meaningful differences in terms of safety and efficacy exist
Biocon and Mylan NV have announced the launch of fulphila, a biosimilar to neulasta (pegfilgrastim). Fulphila is approved by Health Canada to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.
The 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 neulasta and no clinically meaningful differences in terms of safety and efficacy exist.
Dr Christiane Hamacher, CEO, Biocon Biologics, said, “We are pleased to expand access to our high quality biosimilar pegfilgrastim to patients in Canada after a successful launch in the US. This is the second biosimilar from our portfolio to be launched in Canada by our partner Mylan and is an endorsement of our science, development and manufacturing capabilities in the area of biologics. We are committed to serve five million patients through our biosimilars portfolio and cross a revenue milestone of $1 billion by FY22.”
David Simpson, Country Manager, Mylan Canada, commented, “As a global leader in the development of complex products, including biosimilar medicines, Mylan is proud to launch fulphila in Canada. We have reached a negotiated agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) to help expand access to treatment and reduce costs for cancer patients. Fulphila is the second biosimilar to be offered by Mylan through the Mylan-Biocon Biologics partnership in Canada and the second biosimilar approved by Health Canada through this collaboration to support cancer patients. With Mylan’s global portfolio of 20 biosimilar and insulin analog products in development or on the market, we are bringing vast biosimilars experience to the market here in Canada. Among these products is an extensive oncology portfolio increasing choice and access for patients across the region.”
A suite of patient services will be available at launch to further support patients and caregivers with treatment.