Innovent and Coherus Strike Licensing Agreement for Avastin Biosimilar
China’s Innovent Biologics forged a licensing agreement with biosimilar-focused Coherus BioSciences to commercialize Innovent’s biosimilar candidate to Avastin (bevacizumab) in the United States and Canada.
The biosimilar candidate, IBI305, completed a Phase III study in China and was granted Priority Review by that country’s National Medical Products Administration (NMPA). California-based Coherus will file a Biologics License Application with the U.S. Food and Drug Administration in late 2020 or early 2021 depending on the regulatory agency’s interaction timing. Upon approval, coheres will launch the drug as quickly as possible.
IBI305 is a biosimilar product candidate of Avastin and a recombinant humanized anti-VEGF monoclonal antibody for injection. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK.
Results from the late-stage study comparing Innovent’s biosimilar to Avastin as a first-line treatment of advanced non-small cell lung cancer showed overall response rates (ORR) of 47.1% and 46.8% in IBI305 and Avastin, respectively. Median progression-free survival in the IBI305 and Avastin groups was 7.3 months and 7.5 months, respectively, with no statistical difference, Innovent said at the Chinese Society of Clinical Oncology meeting in September 2019.
Results were also presented earlier in 2019 at the American Society of Clinical Oncology. Michael Yu, chairman and chief executive officer of Innovent, said the results from the trial are encouraging and shows that IBI305 “is expected to be high-quality and effective therapy for patients with solid tumors.” Yu noted that Coherus’ Udenyca, a biosimilar to Amgen’s Neulasta, approved by the FDA in 2018, has been the most successful biosimilar launch in the United States. Yu said that made Coherus the ideal partner of choice for Innovent.
“Coherus and Innovent share a very similar mission, vision and set of values. We are pleased to be working together to expand the products’ presence in the U.S. and benefit more patients globally,” Yu said in a statement.
Denny Lanfear, chairman and CEO of Coherus, also expressed his excitement. He said the Chinese company’s “oncology therapeutics complement Udenyca and advance our core mission to expand choice, improve patient access and lower healthcare costs in the United States.”
In addition to the licensing deal for IBI305m Coherus also has a non-exclusive option to license Innovent’s biosimilar to Rituxan (rituximab) IBI301 for development and commercialization in the United States and Canada. IBI301 was filed for approval and accepted by the NMPA in China in June 2019 with priority review status.
IBI301 is a potential biosimilar of rituximab, a recombinant human-mouse chimeric anti-CD20 monoclonal antibody for injection, and is being co-developed by Innovent and Eli Lilly and Company. Rituximab binds to the CD20 antigen on the surface of B lymphocytes and mediates complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC).
Under terms of the deal, Coherus will pay Innovent up to $45 million in upfront and milestone payments for IBI305. In addition, Coherus will also pay double-digit percent of royalty payments based on future sales of IBI305.