FDA approval for pegfilgrastim biosimilar Fulphila

Biosimilars/News | Posted 08/06/2018 post-comment0 Post your comment

The US Food and Drug Administration (FDA) announced on 4 June 2018 that it had approved its first pegfilgrastim biosimilar.

Filgrastim V14K20

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].

Related article
Mylan and Biocon submit insulin glargine biosimilar to EMA

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: Mylan, US FDA

comment icon Comments (0)
Post your comment
Related content
EC approval of first ustekinumab biosimilar Uzpruvo
IBD 1
Biosimilars/News Posted 16/01/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010