Medicines And Healthcare Products Regulatory Agency (MHRA) Approves Bio-Thera Solutions' Qletli (adalimumab), A Biosimilar Referencing Humira

Bio-Thera Solutions Inc. , a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the MHRA has approved Qletli (adalimumab), a biosimilar of Humira, for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, crohn’s disease, ulcerative colitis, uveitis in adults, and polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis and uveitis in paediatric.

“The approval of Qletli by MHRA is an important accomplishment for Bio-Thera,” said Shengfeng Li, CEO at Bio-Thera. “Improving patient access to important treatments is the promise of biosimilars and Bio-Thera continues to fulfill that promise through the continued development of our growing biosimilar pipeline of approved products.”

In November 2019, Qletli was approved by the National Medical Products Administration (NMPA) of China, making it the first adalimumab biosimilar approved in the country and the only one available in two specifications for eight therapeutic indications. Qletli is also under regulatory review in other countries around the world.

About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: Qletli (adalimumab) in China and the UK, BETAGRIN (bevifibatide citrate injection) in China, STARJEMZA (ustekinumab) in the US and Usymro (ustekinumab) in EU, and TOFIDENCE/BAT1806 (tocilizumab) and AVZIVI (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY in China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, visit www.bio-thera.com/en/.