Biocon and Mylan Launch Fulphila (biosimilar- Pegfilgrastim) in Australia
Shots:
- The companies launched Fulphila- a biosimilar referencing Neulasta (pegfilgrastim) in Australia. The biosimilar received TGA’s approval to treat cancer patients following the CT- to decrease the duration of neutropenia and to reduce the incidence of infections- as manifested by febrile neutropenia
- The approval is based on analytical- clinical and nonclinical data which demonstrated that the Fulphila showed bio-similarity to Neulasta and no clinically meaningful differences in terms of safety and efficacy exist
- Fulphila is the first biosimilar pegfilgrastim to be approved in the US and was successfully launched in July’2018 and has received regulatory approval in 30+ countries across the globe. The therapy is the third biosimilar to be commercialized in Australia and is available on PBS
Click here to read full press release/ article | Ref: Biocon | Image: Pinterest
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