Innovent Seeks Chinese Regulatory Approval for Proposed Biosimilar Bevacizumab
Innovent Biologics, a China-based biopharmaceutical company, recently submitted a New Drug Application for its proposed bevacizumab biosimilar, IBI-305, referencing Avastin, to the Chinese regulatory agency, the National Medical Products Administration.
Innovent Biologics, a China-based biopharmaceutical company, recently submitted a New Drug Application for its proposed bevacizumab biosimilar, IBI-305, referencing Avastin, to the Chinese regulatory agency, the National Medical Products Administration (NMPA).
The application is seeking regulatory approval for the treatment of non—small cell lung cancer (NSCLC), colorectal cancer, and other malignant tumors. The application submitted to the NMPA was based on clinical data from 2 studies: a phase 3 study that compared the efficacy and safety of the biosimilar with the reference product in advanced non-squamous NSCLC, and a trial that investigated the pharmacokinetics of both drugs in healthy subjects.
“Two clinical studies have been conducted with bevacizumab injection as the control drug. based on the high-quality clinical data, the NDA application of IBI-305 has been accepted by the NMPA. We believe that the high quality bevacizumab biosimilar will improve drug availability and benefit more patients and their families,” said Li Zhang, professor at the cancer hospital of Sun Yat-Sen University in a statement.
“Our team will continue to deliver high quality biopharmaceutical drugs from our rich pipeline to benefit more ordinary people in China and globally,” added Michael Yu, founder, chief executive officer and chairman of Innovent.
According to Innovent, though there is a demand for effective cancer therapies in China, due to the high cost of reference bevacizumab, uptake of the therapy remains low. The potential approval of a biosimilar candidate is expected to offer a more affordable option for patients.
This submission marks the company’s third application that has been accepted by the NMPA. Most recently, Innovent submitted an NDA for a proposed adalimumab biosimilar, seeking indications for the treatment of ankylosing spondylitis, rheumatoid arthritis, and psoriasis. Innovent’s pipeline consists of 1 other potential biosimilar undergoing a phase 3 trial: IBI-301, a proposed biosimilar rituximab.
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