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FDA accepts application for adalimumab biosimilar CHS-1420 Posted 09/04/2021

US-based Coherus BioSciences (Coherus) announced on 17 February 2021 that the US Food and Drug Administration (FDA) had accepted the application for their proposed adalimumab biosimilar CHS-1420.

CHS-1420 is a proposed biosimilar of AbbVie’s Humira (adalimumab). Humira had worldwide sales of US$19.2 billion in 2019 and accounted for approximately 58% of AbbVie’s total net revenues in 2019 [1].

The patents on Humira expired in Europe in June 2017 [1]. 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 eight companies delaying the launch of biosimilars in the US until January 2023 [2, 3].

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Coherus reported positive results from a phase III study of CHS-1420 back in 2017. The results, according to Coherus, demonstrated ‘similarity between CHS‑1420 and Humira’ [4].

CHS-1420, if approved, will be the second product from Coherus to be approved in the US. The company had its pegfilgrastim biosimilar, Udenyca (pegfilgrastim-cbqv), approved by FDA in November 2018 [5].

FDA has set a Biosimilar User Fee Act action date for CHS-1420 for December 2021. If approved, Coherus plans to launch the adalimumab biosimilar in the US on or after 1 July 2023, under the terms of its agreement with AbbVie [3]. The company is also planning to launch bevacizumab and ranibizumab biosimilars in the US by 2023.

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Judge rules in AbbVie’s favour over biosimilar delay deals

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab 
2. GaBI Online - Generics and Biosimilars Initiative. AbbVie makes more deals delaying adalimumab biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9] Available from: www.gabionline.net/Pharma-News/AbbVie-makes-more-deals-delaying-adalimumab-biosimilars-in-the-US 
3. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Coherus sign licensing deal for Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9] Available from: www.gabionline.net/Pharma-News/AbbVie-and-Coherus-sign-licensing-deal-for-Humira-biosimilar 
4. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for adalimumab biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-adalimumab-biosimilar-from-Coherus 
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US 

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Source: Coherus

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