US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.
Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.
Fulphila (MYL‑1401H) has been approved by Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections, as manifested by febrile neutropenia.
Fulphila is also now available on Australia’s Pharmaceutical Benefits Scheme (PBS)*.
The TGA’s 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 the originator biological, Amgen’s Neulasta, and no clinically meaningful differences in terms of safety and efficacy exist.
Mylan and Biocon have also launched a trastuzumab biosimilar Ogivri [1] and an insulin glargine biosimilar Semglee in Australia [2].
Fulphila (pegfilgrastim-jmdb) was also approved in the US in June 2018 [3] and in Europe in November 2018 [4].
*The PBS is a programme of the Australian Government that provides subsidised prescription drugs to residents of Australia.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan launches first trastuzumab biosimilar in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 4]. Available from: www.gabionline.net/Biosimilars/News/Mylan-launches-first-trastuzumab-biosimilar-in-Australia
2. GaBI Online - Generics and Biosimilars Initiative. Biocon/Mylan launch first insulin glargine biosimilar in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 4]. Available from: www.gabionline.net/Biosimilars/News/Biocon-Mylan-launch-first-insulin-glargine-biosimilar-in-Australia
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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