FDA approves adalimumab and pegfilgrastim biosimilars / News / Biosimilars / Home - GaBi Online

The US Food and Drug Administration (FDA) announced on 30 October 2018 and on 2 November 2018 that it had approved adalimumab and pegfilgrastim biosimilars, respectively.

The adalimumab biosimilar, Hyrimoz (adalimumab-adaz), is produced by Sandoz, the generics division of Novartis. The company submitted its application for approval of the pegfilgrastim biosimilar to FDA in January 2018 [1].

Hyrimoz (GP2017) is a proposed biosimilar to AbbVie’s Humira (adalimumab), which had worldwide sales of US$18.4 in 2017 [2]. The patents on Humira expired in Europe in June 2017 [3]. However, in the US AbbVie has stated that although the composition of matter patent covering Humira expired in December 2016, non-composition of matter patents covering Humira expire no earlier than 2022. The company has therefore made settlement agreements with Amgen and Samsung Bioepis delaying the launch of biosimilars in the US until January 2023 [4, 5].

Hyrimoz was also approved in Europe in July 2018 [6]. There are already two adalimumab biosimilars approved in the US. Amjevita (adalimumab-atto) was approved by FDA in September 2016 and Cyltezo (adalimumab-adbm) was approved in August 2017 [7].

The pegfilgrastim biosimilar, Udenyca (pegfilgrastim-cbqv), is produced by US-based biosimilars specialist Coherus BioSciences (Coherus). The company submitted its application for approval of the pegfilgrastim biosimilar to FDA in October 2016 [8]. The application was delayed, however, after Coherus received a complete response letter (CRL) from the agency saying that it wanted a ‘re-analysis of a subset of subject samples with a revised immunogenicity assay’ and ‘certain additional manufacturing related process information’ [9].

Udenyca (CHS‑1701) 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 [10]. The patents on Neulasta expired in the US in October 2015 and expired in Europe in August 2017 [3].

Udenyca was also approved in Europe in July 2018 [11]. FDA approved its first pegfilgrastim biosimilar Fulphila (pegfilgrastim-jmdb) in June 2018 [12].

Hyrimoz and Udenyca have, however, only been approved as biosimilars, not as interchangeable products. 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.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts applications for adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-applications-for-adalimumab-and-trastuzumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
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. Amgen’s adalimumab biosimilar will only be launched in US in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9] Available from: www.gabionline.net/Biosimilars/News/Amgen-s-adalimumab-biosimilar-will-only-be-launched-in-US-in-2023
5. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Samsung Bioepis reach patent deal over Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9] Available from: www.gabionline.net/Biosimilars/General/AbbVie-and-Samsung-Bioepis-reach-patent-deal-over-Humira-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars gain EC approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-gain-EC-approval
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
8. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
9. GaBI Online - Generics and Biosimilars Initiative. FDA rejects pegfilgratim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-pegfilgrastim-biosimilar-from-Coherus
10. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
11. GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-adalimumab-and-pegfilgrastim-biosimilars-Hulio-and-Udenyca
12. GaBI Online - Generics and Biosimilars Initiative. FDA approval for pegfilgrastim biosimilar Fulphila [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-pegfilgrastim-biosimilar-Fulphila

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Source: Coherus, Sandoz, US FDA