Biocon and Mylan N.V. yesterday 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, 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.
A suite of patient services will be available at launch to further support patients and caregivers with treatment.
Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has shared or co-exclusive commercialization rights with Mylan for the product in the rest of the world.
The announcement was made after market hours yesterday, 28 April 2020. Shares of Biocon lost 3.02% to close at Rs 352.10 on 28 April 2020.
Biocon is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as generic formulations in the US and Europe.
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