California’s Coherus BioSciences will commercialise Innovent Biologic’s Avastin biosimilar in the US and Canada under a new licensing agreement with the Chinese biopharma.
Coherus plans to file a Biologics License Application (BLA) with FDA in late 2020 or early 2021 and to launch directly upon approval.
It anticipates completing a single dose pharmacokinetic clinical study and certain analytical/bioanalytical exercises to support the filing.
The agreement – which also includes the option to commercialise Innovent’s biosimilar to Rituxan (rituximab) in the US and Canada – is part of the company’s strategy to expand its oncology franchise and leverage its commercial infrastructure in the US.
Innovent’s Avastin (bevacizumab) biosimilar successfully completed a large Phase 3 safety and efficacy study in China, and the application was filed for approval and was accepted by the country’s National Medical Products Administration (NMPA) in January 2019, and subsequently granted priority review status.
Coherus will pay up to $45 million in milestones, including the upfront, for the Avastin biosimilar upon achieving certain regulatory and commercialisation goals, as well as customary double-digit royalty payments.
Financial terms for Innovent’s Rituxan biosimilar will be the same when optioned.