Mylan and Biocon have launched their Fulphila (pegfilgrastim) rival to Neulasta in Australia. The biosimilar – which is approved by the country’s Therapeutic Goods Administration for treating cancer patients following chemotherapy to decrease the duration of severe neutropenia and reduce the incidence of infections as manifested by febrile neutropenia – is immediately available on Australia’s Pharmaceutical Benefits Scheme from Mylan’s Alphapharm affiliate.
“The approval of Fulphila was based on a comprehensive package of analytical, non-clinical 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 firms commented, adding that “a
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Generics Bulletin for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?