Innovent Biologics (Suzhou) Co., Ltd., based in China, signed an agreement on January 13, 2020 that allows Coherus Biosciences to commercialize its bevacizumab biosimilar when approved by Canadian and American regulators. The investigational agent is known as IB1305 at present.
Recently completing a phase 3 trial with Chinese patients, Innovent will need to gather the necessarily analytic comparison data for US approval. In its press release, Coherus believes that an FDA submission could be possible in late 2020 or early 2021, based on the Chinese data.
A phase 1 study was listed in ClinicalTrials.gov, which had an estimated completion date of 2017, but there has not been an update to this information. Coherus stated that “The Company anticipates completing a single dose pharmacokinetic clinical study and certain analytical/bioanalytical exercises to support the U.S. filing.” This could mean that a new phase 1 study will be undertaken. Coherus also indicated that it will handle the biologic licensing application process in the US and subsequent marketing in the US and Canada.
Additionally, the press release announced that Innovent’s biosimilar rituximab candidate (IB1301) may also be part of this deal. In June 2019, Innovent filed for approval with the Chinese drug regulatory authorities. According to the terms of the agreement, Coherus has an option to commercialize this agent in North America. IB1301 has been subject to oncology testing in China patients (not to treat autoimmune disorders).
This agreement is significant for Coherus, which is trying to build upon its success in launching the pegfilgrastim biosimilar Udenyca® in the US. Innovent’s biosimilars represent a new oncology pipeline for Coherus in the US and Canada, which already includes two anti-TNF inhibitors (adalimumab and etanercept), and two ophthalmology biosimilars (although aflibercept is still in preclinical development).