Fulphila has received regulatory approval in more than 30 countries around the world.
Biocon and Mylan N.V. on 14 April 2020 announced the launch of Fulphila, a biosimilar to Neulasta (pegfilgrastim), in Australia. Fulphila is approved by the therapeutic goods administration for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections, as manifested by febrile neutropenia.
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. The company also said that Fulphila is available on the pharmaceutical benefits scheme (PBS).
Fulphila, co-developed by Biocon Biologics and Mylan, was the first biosimilar pegfilgrastim to be approved in the U.S. and was successfully launched in July 2018. The drug has received regulatory approval in more than 30 countries around the world.
Shares of Biocon closed 2.05% higher to Rs 340.40 on Monday. The stock also hit a fresh 52-week high of Rs 355.20 in yesterday's trading session. The stock has surged 18.34% in last one month as compared to a 10% fall in benchmark BSE Sensex.
Biocon is an innovation-led global bio-pharmaceuticals company. Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. The biosimilar pegfilgrastim is one of the 11 biologic products being co-developed by Mylan and Biocon for the global marketplace. 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 co-exclusive commercialization rights with Mylan for the product in the rest of the world.
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