Innovent Biologics Inc.'s new drug application for IBI303, a biosimilar candidate to AbbVie Inc.'s Humira, was accepted for review in China.
Humira, or adalimumab, generated $18.43 billion in 2017 sales. The blockbuster drug is used to treat autoimmune disorders such as rheumatoid arthritis, plaque psoriasis and ulcerative colitis.
Innovent's submission to the National Medical Products Administration included data from three clinical studies. Late-stage trials compared IBI303's efficacy and safety with Humira's in patients with ankylosing spondylitis, a type of arthritis that affects the spine.
The company said Humira has a relatively low adoption rate in China, despite large clinical demand for similar drugs.
"Because of the high price of the branded drug, many patients in China have difficulty getting treatment for these chronic diseases which require long-term medication," Innovent COO Qinwei Zhou said in a news release. The company said IBI303 offers an affordable alternative to Humira.
