Biocon, Mylan launch Fulphila, biosimilar pegfilgrastim, in Canada

Biocon Ltd. and Mylan N.V.onTuesday announced the launch of Fulphila, a biosimilar toNeulasta (pegfilgrastim), in Canada

Fulphila is approved by Health Canada to decrease theincidence of infection, as manifested by febrile neutropenia,in patients with non-myeloid malignancies receivingmyelosuppressive anti-neoplastic drugs, Bengaluru-headquartered Biocon said in a statement

The approval of Fulphila was based on a comprehensivepackage of analytical, nonclinical and clinical data, whichconfirmed that the product is highly similar to Neulasta andno clinically meaningful differences in terms of safety andefficacy exist, it said.PTI RS SSPTI PTI