Coherus signs licensing deal for bevacizumab biosimilar in the US

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Coherus signs licensing deal for bevacizumab biosimilar in the US

Home/Pharma News | Posted 07/02/2020 0 Post your comment

US-based Coherus BioSciences (Coherus) announced on 13 January 2020 that it had entered into a licensing agreement with Chinese biopharmaceutical firm Innovent Biologics (Innovent) for its bevacizumab product, IBI305.

Under the terms of the agreement, Coherus will gain the rights to commercialize Innovent’s biosimilar candidate to Avastin (bevacizumab) in Canada and the US. Coherus will pay up to US$45 million in milestones, including an upfront payment, for its Avastin biosimilar upon achieving certain regulatory and commercialization goals, as well as customary double-digit royalty payments.

In June 2019, Innovent announced positive phase III results for IBI305 from a large safety and efficacy study carried out in China [1]. The application for approval of IBI305 was filed for approval and was accepted by China’s regulatory agency, the National Medical Products Administration (NMPA), in January 2019 and subsequently granted priority review status.

In addition to the bevacizumab product, Coherus has also acquired the option to commercialize Innovent’s rituximab product, IBI301, in Canada and the US. IBI301 was filed for approval and accepted by China’s NMPA in June 2019 [2] and was also subsequently granted priority review status. Financial terms for Innovent’s candidate biosimilar to Rituxan (rituximab) will be the same as for the bevacizumab product if the option is taken.

Coherus plans to file a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) in late 2020 or early 2021 depending on the FDA interaction timing, and to launch directly upon approval. The company anticipates completing a single-dose pharmacokinetic clinical study and certain analytical/bioanalytical exercises to support the US filing.

Coherus already has a biosimilar approved in the US. Udenyca (pegfilgrastim-cbqv) was approved by FDA in November 2018 [3]. The company has also acquired rights to commercialize Bioeq’s Lucentis (ranibizumab) biosimilar, FYB201, in the US.

Denny Lanfear, Chairman and Chief Executive of Coherus says that Innovent’s oncology therapeutics ‘complement Udenyca and advance our core mission to expand choice, improve patient access and lower healthcare costs in the United States’.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for bevacizumab copy biological IBI305 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-bevacizumab-copy-biological-IBI305
2. GaBI Online - Generics and Biosimilars Initiative. Rituximab copy biological accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-copy-biological-accepted-for-review-in-China
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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Source: Coherus, Innovent