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CHRS

Coherus Biosciences

$17.71 /

+0.12 (+0.68%)

08:47
01/13/20
01/13
08:47
01/13/20
08:47

Coherus acquires commercial rights for Avastin biosimilar in the U.S.

Coherus BioSciences announced the Company has entered into a licensing agreement with Innovent Biologics, a leading biopharmaceutical company headquartered in China, to commercialize Innovent's biosimilar candidate to Avastin in the United States and Canada. Coherus plans to file a Biologics License Application with the U.S. Food and Drug Administration in late 2020 or early 2021 depending on 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 U.S. filing. Innovent's Avastin 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 National Medical Products Administration in China in January 2019, and subsequently granted priority review status. Also, under the terms of the agreement, Coherus acquired an option to commercialize Innovent's biosimilar to Rituxan in the United States and Canada. Innovent's Rituxan biosimilar was filed for approval and accepted by the NMPA in China in June 2019, and subsequently granted priority review status. The agreement furthers the Company's previously-stated strategic objective to expand its oncology franchise and leverage its commercial infrastructure in the United States. Coherus expects to apply its biosimilar regulatory expertise to convert the Chinese regulatory filing into a FDA biologics application. Oncology is one of three focus areas for the Company along with ophthalmology and immunology. In the fourth quarter of 2019, Coherus announced it had acquired rights to commercialize BioEq's Lucentis biosimilar in the United States, the lead asset in Coherus' ophthalmology franchise. According to the terms of the agreement with Innovent, Coherus will pay up to $45 million in milestones, including the upfront, for its Avastin biosimilar upon achieving certain regulatory and commercialization goals, as well as customary double-digit royalty payments. Financial terms for Innovent's Rituxan biosimilar will be the same when optioned.

  • 13

    Jan

CHRS Coherus Biosciences
$17.71 /

+0.12 (+0.68%)

09/25/19 LEHM
Coherus remains top pick amid Udenyca momentum, says Barclays
09/25/19 MZHO
Coherus still guiding to 20% exit pegfilgrastim volume market share, says Mizuho
11/20/19 LEHM
Symphony data another positive data point for Coherus, says Barclays
11/27/19 MZHO
Coherus Biosciences said to cancel from conference next week, says Mizuho

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