Mylan and Biocon have launched Fulphila, a biosimilar to Neulasta (pegfilgrastim), as it was 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, nonclinical 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, Mylan said in the press release.
Mylan Canada Country Manager David Simpson said that the company has reached a negotiated agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) to help expand access to treatment and reduce costs for cancer patients. Simpson said that 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.”
Biocon Biologics CEO, Dr Christiane Hamacher said, “We are pleased to expand access to our high quality biosimilar pegfilgrastim to patients in Canada, after a successful launch in the U.S. 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 5 million patients through our biosimilars portfolio and cross a revenue milestone of US$1bn by FY22.”