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Coherus Acquires Commercial Rights for Avastin® Biosimilar in the United States
Agreement Includes an Option for Rituxan® Biosimilar REDWOOD CITY, Calif., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the
About this update from Coherus Oncology, Inc.
[{"type":"text","content":"Agreement Includes an Option for Rituxan® Biosimilar\nREDWOOD CITY, Calif., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq: CHRS), today announced the Company has entered into a licensing agreement with Innovent Biologics, (Suzhou) Co., Ltd., (“Innovent”), a leading biopharmaceutical company headquartered in China, to commercialize Innovent’s biosimilar candidate to Avastin® (bevacizumab) in the United States and Canada. Coherus plans to file a Biologics License Application (“BLA”) with the U.S. Food and Drug Administration (“FDA”) 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 (“NMPA”) 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® (rituximab) 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.\n 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. “We are excited to enter into a strategic collaboration with one of the premier Chinese biologics companies,” said Denny Lanfear, Chairman and Chief Executive of Coherus. “Innovent is an impressive fully-integrated organization delivering substantial benefits to the healthcare system and patients in China with their first approved and successfully commercialized PD-1. Its oncology therapeutics complement UDENYCA® and advance our core mission to expand choice, improve patient access and lower healthcare costs in the United States.” “UDENYCA® has been the most successful biosimilar launch in the Unit...