With its approval by China’s National Medical Products Administration (NMPA) last November, Qletli (which is marketed by Bio-Thera Solutions) became the first biosimilar of AbbVie‘s Humira in the country, and the second biosimilar approved by the NMPA.
Biosimilars are medicines nearly identical to their reference biologic medications (in this case Humira), but are developed and produced by a different company after the patent of the reference medication expires. Although they have the same mechanism of action as the original therapy, biosimilars tend to be less expensive.
Qletli (previously known as BAT1406), like Humira, is an antibody that blocks TNF-alpha, which is a pro-inflammatory molecule highly produced in AS patients and has a critical role in disease development.
The new biosimilar is sold as a prefilled syringe for subcutaneous (under-the-skin) injection.
“The commercial launch of Bio-Thera’s first approved product is an enormous milestone for the company,” Shengfeng Li, PhD, Bio-Thera’s CEO, said in a press release. “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.”
According to Bio-Thera, Qletli’s approval was based on a comprehensive data package that supported the therapy’s similarity to Humira, including analytical, nonclinical, pharmacological, and clinical data.
A Phase 3 clinical study (NCT04135508) with 554 participants showed no clinically meaningful differences in safety, immunogenicity (the ability to induce an immune reaction), and efficacy between Qletli and Humira. Both treatments were given once every two weeks for up to six months.
Qletli is the first approved biosimilar for Bio-Thera, which is currently developing BAT1806, a biosimilar to Roche‘s Actemra/RoActemra (tocilizumab), and BAT1706, a biosimilar to Genentech‘s Avastin (bevacizumab).
Both biosimilar candidates are being compared with their reference products in global Phase 3 trials: BAT1806 in patients with rheumatoid arthritis (NCT03830203) and BAT1706 in participants with advanced non squamous non-small-cell lung cancer (NCT03329911).
In addition, Bio-Thera is developing BAT2506, a biosimilar to Janssen’s Simponi (golimumab) (NCT04152759) which treats AS and other inflammatory disorders, as well as a biosimilar to Stelara (ustekinumab) for Crohn’s disease.