Biocon Ltd. and Mylan N.V.on
Tuesday announced the launch of Fulphila, a biosimilar to Neulasta (pegfilgrastim), in Canada.
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, Bengaluru- headquartered Biocon said in a statement.
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, it said.
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