Coherus BioSciences (Coherus) announced in January 2019 that it had entered into global settlement agreements with AbbVie which resolve all pending disputes related to CHS-1420, Coherus’s proposed biosimilar of AbbVie’s Humira (adalimumab).
Under the terms of the settlement, Coherus will have global non-exclusive licence rights to commercialize CHS-1420 and will pay royalties to AbbVie. The licence period for CHS-1420 in the US will begin on 15 December 2023.
Coherus anticipates submitting its biologicals licence application for CHS-1420 to the US Food and Drug Administration in late 2019. Coherus believes that following US launch, which is expected in late 2023, it will be able to effectively leverage the commercial infrastructure it has already deployed for its recent US launch of Udenyca (pegfilgrastim-cbqv) . Coherus reports that it will continue to evaluate options and potential strategies for commercialization of CHS-1420 outside the US.
‘Biosimilars have an essential role in our healthcare system to restrain cost increases while expanding access for patients,’ said Denny Lanfear, Chairman, President and CEO of Coherus. ‘We expect to launch CHS-1420 with our own sales force and deliver significant top-line growth thereafter.’
Coherus is the eighth developer to enter into a patent licence agreement with AbbVie regarding the authorization of a Humira biosimilar in the US. Pfizer, Amgen, Mylan, Samsung Bioepis, Sandoz, Fresenius Kabi and Momenta have all entered into agreements with AbbVie, with terms that ensure no biosimilar of Humira enters the US market before January 2023 . Boehringer Ingelheim is the only developer with an approved adalimumab biosimilar which has not entered into a settlement with AbbVie .
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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars launched in the US at a significant discount [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 5]. Available from: www.gabionline.net/Biosimilars/News/Biosimilars-launched-in-the-US-at-a-significant-discount
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 2019 Apr 5]. Available from: www.gabionline.net/Pharma-News/AbbVie-makes-more-deals-delaying-adalimumab-biosimilars-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Boehringer wins access to Humira documents as Janssen’s Remicade is relisted in Quebec [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 5]. Available from: www.gabionline.net/Pharma-News/Boehringer-wins-access-to-Humira-documents-as-Janssen-s-Remicade-is-relisted-in-Quebec
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