India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 2 June 2021 that the US Food and Drug Administration (FDA) had accepted the application for approval for its proposed pegfilgrastim biosimilar.
Lupin’s product is a proposed biosimilar of Amgen’s Neulasta (pegfilgrastim). Neulasta had worldwide sales of US$4.7 billion in 2016, before the advent of biosimilars [1]. The patents on Neulasta expired in the US in October 2015 and expired in Europe in August 2017 [2].
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.
This product is the first biosimilar application to be filed by Lupin in the US. Biosimilars are a key part of the growth strategy of the company and, according to Nilesh Gupta, MD, Lupin, the filing ‘is a milestone in our research and innovation journey as we continue to focus on delivering unique and affordable solutions to alleviate disease burden’.
The submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies.
Lupin is also planning to launch its etanercept biosimilar in the US [3]. Lupin’s biosimilar of etanercept was approved in Japan in March 2019 [4] and in Europe (as Nepexto) in May 2020 [5], where it is being sold by partner Mylan [6].
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘non-originator biologicals’ approved in outside of Europe might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. Lupin to launch etanercept and pegfilgrastim biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 21]. Available from: www.gabionline.net/Biosimilars/News/Lupin-to-launch-etanercept-and-pegfilgrastim-biosimilars-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for Lupin’s etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 21]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-Lupin-s-etanercept-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
6. GaBI Online - Generics and Biosimilars Initiative. Mylan and Lupin make deal for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 21]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Lupin-make-deal-for-etanercept-biosimilar
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