 "The approval of Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data")
Biocon Ltd. and Mylan N V on Tuesday 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 reduce the incidence of infections, as manifested by febrile neutropenia, city-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.
