Mylan and Biocon Launch Pegfilgrastim Biosimilar in Canada

Mylan and Biocon said they have launched their pegfilgrastim biosimilar (Fulphila) in Canada for the treatment of febrile neutropenia, a condition of low white blood cell count, for patients receiving myelosuppressive antineoplastic drugs as part of chemotherapy.

“As a global leader in the development of complex products, including biosimilar medicines, Mylan is proud to launch Fulphila in Canada,” said Mylan Canada Country Manager David Simpson in a release.

Mylan and Biocon said the Canadian approval for Fulphila was based on an analysis of nonclinical and clinical data, which confirmed biosimilarity to reference pegfilgrastim, Neulasta, and showed no clinically meaningful differences in terms of safety and efficacy.

“We have reached a negotiated agreement with the Pan-Canadian Pharmaceutical Alliance to help expand access to treatment and reduce costs” for patients with cancer, Simpson said.

More on the Mylan/Biocon Partnership

Mylan and Biocon have also produced the trastuzumab biosimilar (Ogivri), referencing Herceptin. Ogivri was launched in the United States late in 2019. It is also approved for marketing in Canada. The 2 companies have a pipeline of 11 biologic products under development for the global market.

“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," Simpson said.

Fulphila Around the World

Currently, Fulphila is marketed in the United States and, as of earlier this month, Australia. Fulphila received marketing approval from the European Medicines Agency in late 2018.

Mylan has exclusive commercialization rights for Fulphila in the United States, Canada, Japan, Australia, New Zealand, and the European Union and European Free Trade Association countries.