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.
CEO of Biocon Biologics, Dr Christiane Hamacher said, Fulphila, co-developed by Biocon Biologics and Mylan, is the third biosimilar to be commercialised in Australia and we hope that continued penetration of our biosimilars will enable higher cost savings for the Australian healthcare system.
Fulphila was the first biosimilar pegfilgrastim to be approved in the US and was successfully launched in July 2018, thus expanding access for patients in need of an affordable alternative.
Fulphila has received regulatory approval in more than 30 countries, the statement said.
