Biocon, Mylan launch biosimilar Fulphila in Canada

Biotechnology major Biocon and drug firm Mylan on Tuesday announced the launch of Fulphila , a biosimilar pegfilgrastim, in Canada after getting approval from the health regulator.

"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," Biocon Biologics CEO Christiane Hamacher said.

Fulphila is approved by Health Canadato decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs, the companies said in a joint statement.

"Fulphila is the second biosimilar to be offered by Mylan through the Mylan-Biocon Biologics partnership in Canada and the second biosimilar approved by Health Canada through this collaboration to support cancer patients," Mylan Canada Country Manager David Simpson said.

As a global leader in the development of complex products, including biosimilar medicines, Mylan is proud to launch Fulphila in Canada, he added.

Biosimilar pegfilgrastim is one of the 11 biologic products being co-developed by Mylan and Biocon for the global market.

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

Biocon has shared or co-exclusive commercialisation rights with Mylan for the product in the rest of the world.

Shares of Biocon Ltd closed at Rs352.10per scrip on the BSE, down 3.02 per cent from its previous close.