Chinese pharmaceutical company Bio-Thera Solutions has received approval from the country’s National Medical Products Administration (NMPA) for Qletli, a biosimilar to AbbVie’s Humira (adalimumab).
Qletli is an anti-TNF- α monoclonal antibody. The drug secured approval for all eligible indications of Humira, including rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.
It is said to be the first Humira biosimilar approved in China. Qletli is available in prefilled syringes for subcutaneous administration.
Bio-Thera Solutions CEO Shengfeng Li said: “The NMPA approval of Qletli is a very important milestone for our biosimilar portfolio, providing a new affordable treatment option for patients in China with several types of autoimmune diseases.
“Qletli is the first biosimilar from our portfolio to receive regulatory approval. We look forward to seeking approvals of Qletli in other regulated markets around the world.”
The China NMPA approval was based on a comprehensive data package, including analytical, non-clinical, pharmacokinetics, pharmacodynamics and clinical data.
A Phase III clinical trial of the drug met its primary endpoint with no clinically meaningful differences in safety, immunogenicity and efficacy when compared to adalimumab.
Last year, Humira fetched $20bn in sales, according to Reuters. AbbVie’s drug lost patent protection in Europe, where many cheaper biosimilar versions of the drug have been launched.
Humira’s US patents are set to expire in 2023. Multiple pharmaceutical companies have already secured the US Food and Drug Administration’s (FDA) approval for Humira biosimilars, including Samsung Bioepis and Novartis subsidiary Sandoz.
In addition to Qletli, Bio-Thera is developing several proposed biosimilars, including those of Avastin and Actemra / RoActemra, which are undergoing global Phase III trials.
The company is also working on biosimilar versions of Simponi and Stelara.