The US Food and Drug Administration (FDA) announced on 4 June 2018 that it had approved its first pegfilgrastim biosimilar.
The pegfilgrastim biosimilar, Fulphila (pegfilgrastim-jmdb), is produced by generics giant Mylan Pharmaceuticals (Mylan) and Indian biotech major Biocon. The companies submitted their application for approval of the pegfilgrastim biosimilar to FDA in February 2017. The application was delayed, however, after Biocon received a complete response letter (CRL) from the agency relating to the update of the biosimilar application with chemistry, manufacturing and control (CMC) data after Biocon made plant modifications requiring ‘requalification’ at its Bangalore facility [1].
Fulphila is a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), which had worldwide sales of US$4.7 billion in 2016, before the advent of biosimilar competition [2]. The patents on Neulasta expired in the US in October 2015 and expired in Europe in August 2017 [3].
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 FDA’s approval of Fulphila is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Fulphila is biosimilar to Neulasta. It has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils) in patients treated with chemotherapy in certain types of cancer.
Fulphila has, however, only 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.
Fulphila is the second biosimilar from Biocon and Mylan’s joint portfolio approved in the US. The companies are exclusive partners on a broad portfolio of biosimilars and have already received approval for their trastuzumab biosimilar Ogivri (trastuzumab-dkst) in the US [4]. The companies have also submitted an application for approval of their candidate pegfilgrastim biosimilar (MYL‑1401H) to the European Medicines Agency [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA delays approval of Biocon/Mylan’s pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-delays-approval-of-Biocon-Mylan-s-pegfilgrastim-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
3. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Ogivri [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Ogivri
5. GaBI Online - Generics and Biosimilars Initiative. EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 8]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-applications-for-pegfilgrastim-and-trastuzumab-biosimilars-from-Biocon-Mylan
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