It is the first adalimumab biosimilar approved by the China National Medical Products Administration.
Bio-Thera Solutions said Friday that Qleti, a biosimilar adalimumab referencing Humira, is now available in China.
It is the first adalimumab biosimilar approved by the China National Medical Products Administration (NMPA) and is authorized for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.
Bio-Thera's said it is the first of its biosimilars to receive regulatory approval and is the second biosimilar approved in China by the NMPA.
Bio-Thera announced in July 2019 that the biosimilar, BAT1406, had met its primary end point of equivalent efficacy to reference adalimumab in a phase 3 trial conducted in patients with active ankylosing spondylitis.
The application submitted to the regulatory authorities included a comprehensive data package that consists of analytical, preclinical, and clinical data. The clinical studies included a trial that investigated pharmacokinetic and pharmacodynamic data, as well as the phase 3 study in AS.
The drug maker is also developing biosimilar candidates of bevacizumab, tocilizumab, ustekinumab, and golimumab.
“The commercial launch of Bio-Thera’s first approved product is an enormous milestone for the company," said Shengfeng Li, PhD, chief executive officer of Bio-Thera Solutions, in a statement. "It demonstrates that Bio-Thera Solutions is a fully-integrated pharmaceutical company, able to take a product developed in our labs, through the clinic, through regulatory approval and now to the market. Bio-Thera is committed to bringing additional biosimilar and innovative products to the market in China and around the world."