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Biocon and Mylan Launch Fulphila (biosimilar- Pegfilgrastim) in Australia

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Biocon and Mylan Launch Fulphila (biosimilar- Pegfilgrastim) in Australia

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  • 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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