Sandoz, the generics division of Novartis, announced on 5 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Ziextenzo (LA-EP2006).
Ziextenzo (pegfilgrastim-bmez) is a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), which 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 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.
Sandoz first applied for FDA approval for its proposed pegfilgrastim biosimilar LA-EP2006 back in November 2015 [3]. However, FDA rejected the application in July 2016 [4]. The company then resubmitted its application for approval in April 2019 [5].
Ziextenzo is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Ziextenzo has been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.
FDA approval of Ziextenzo was based on analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study (LA-EP06-104). This study compared Sandoz pegfilgrastim with US-sourced reference pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim. PK and PD similarity were demonstrated in all three comparisons, and no clinically meaningful differences were observed regarding safety and immunogenicity among the treatment groups.
The approval of Ziextenzo marks the fourth biosimilar from Sandoz approved by FDA. Zarxio (filgrastim-sndz) was approved in March 2015, Erelzi (etanercept-szzs) in August 2016 and Hyrimoz (adalimumab-adaz) in October 2018 [6].
Ziextenzo is the third pegfilgrastim biosimilar approved by FDA. Biocon/Mylan’s Fulphila (pegfilgrastim-jmdb) was approved in June 2018 [7] and Udenyca (pegfilgrastim-cbqv) from Coherus Biosciences was approved in November 2018 [8]. Ziextenzo was also approved in Europe in November 2018 [9].
Sandoz says it ‘is [the] first and only company to offer US physicians long- and short-acting filgrastim biosimilar treatment options’. It adds that ‘each year in the US, more than 60,000 cancer patients are hospitalized with evidence of neutropenia, including fever or infection, with more than 4,000 deaths as a result’.
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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 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
2. Derbyshire M, Shina S. Patent expiry dates for best-selling 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. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. FDA rejects Sandoz’s biosimilar pegfilgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Sandoz-s-biosimilar-pegfilgrastim-application
5. GaBI Online - Generics and Biosimilars Initiative. Sandoz resubmits pegfilgrastim biosimilar to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-resubmits-pegfilgrastim-biosimilar-to-FDA
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
7. GaBI Online - Generics and Biosimilars Initiative. FDA approval for pegfilgrastim biosimilar Fulphila [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-pegfilgrastim-biosimilar-Fulphila
8. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-and-pegfilgrastim-biosimilars
9. GaBI Online - Generics and Biosimilars Initiative. EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-pegfilgrastim-biosimilars-Pelmeg-and-Ziextenzo
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