Biocon, Mylan Launch Fulphila, Biosimilar Pegfilgrastim in Canada
Bengaluru: Biocon Ltd. and Mylan N.V. 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, 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.
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 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 5 million patients through our biosimilars portfolio and cross a revenue milestone of US$1bn by FY22."
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