India-based generics maker Aurobindo Pharma (Aurobindo) announced on 22 September 2021 that its subsidiary CuraTeQ Biologics (CuraTeQ) had submitted an application to the European Medicines Agency (EMA) for its pegfilgrastim biosimilar, BP14.
BP14 is a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim). 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.
The originator product, Amgen’s Neulasta (pegfilgrastim) had worldwide sales of US$4.7 billion in 2016, before the advent of biosimilars. The patents on Neulasta expired in the US in October 2015 and in Europe in August 2017 [1].
Dr Satakarni Makkapati, CEO of CuraTeQ, said that the submission of BP14 with EMA ‘is an important beginning in our business evolution and positions CuraTeQ well in our mission of providing access to high quality biosimilars for cancer patients’.
If approved, BP14 will be the first biosimilar product from Aurobindo’s pipeline. The company transferred its entire biosimilars business to its subsidiary company CuraTeQ Biologics, a Swiss company based in Lucerne, in 2020 [2]. However, the company also says that it remains ‘on track’ for filing its second biosimilar in 2021.
The company completed a phase I trial for a subcutaneous version of BP14 in healthy volunteers in Australia in February 2021. While it also states that ‘another biosimilar from our oncology portfolio, currently in Phase III clinical studies has reached the 50% patient recruitment milestone’.
As well as pegfilgrastim, the company is also working on bevacizumab, filgrastim and trastuzumab biosimilars [3-5].
Source: Aurobindo
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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Aurobindo and Huons refocus their biologicals/biosimilars portfolios [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 8]. Available from: www.gabionline.net/pharma-news/Aurobindo-and-Huons-refocus-their-biologicals-biosimilars-portfolios
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 8]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 8]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-filgrastim
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 8]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-trastuzumab
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