Eye on Pharma: Innovent Seeks Chinese Regulatory Approval for Biosimilar Adalimumab

Earlier this week, Innovent Biologics, a China-based biopharmaceutical company, announced that its new drug application for its proposed adalimumab biosimilar IBI303, referencing Humira, was accepted by the National Medical Products Administration (NMPA, formerly known as the China Food and Drug Administration).

The application was accepted based on analytical, clinical, and pharmacokinetic (PK) data generated by 3 clinical studies. Innovent is seeking indications for the treatment of ankylosing spondylitis, rheumatoid arthritis, and psoriasis. Phase 3 comparative efficacy and safety studies were conducted in patients with ankylosing spondylitis. In addition, researchers also analyzed and compared PK parameters and immunogenicity of IBI303 versus reference adalimumab.

“Innovent successfully developed IBI303, which will provide as an alternative to the branded original product. Because of the high price of the branded drug, many patients in China have difficulty getting treatment for these chronic disease[s] which require long-term medication,” said Qinwei Zhou, MD, chief operating officer at Innovent. “We believe IBI303 will become a high-quality biosimilar drug for Chinese patients.”

Michael Yu, the founder, CEO, and chairman of Innovent explained that IBI303 is the second new drug application that the company has submitted to the NMPA. Within its pipeline, Innovent has 2 other potential biosimilars currently undergoing phase 3 clinical trials: IBI301, a proposed biosimilar rituximab, and IBI305, a proposed biosimilar bevacizumab.

“We are excited about reaching this important milestone much quicker than we originally planned. Our team will continue to deliver high-quality biopharmaceutical drug[s] from our rich pipeline to benefit more ordinary people,” said Yu.