Therapy Areas: Autoimmune
China National Drug Administration Accepts Biologics License Application for Proposed Biosimilar to Humira 
22 August 2018 - - The China National Drug Administration has accepted for review the Biologics License Application for BAT1406, a proposed biosimilar to Humira1 (adalimumab), which is used to treat patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis, Chinese biopharmaceutical company Bio-Thera Solutions said.

The BLA for BAT1406 is the first BLA for a proposed adalimumab biosimilar accepted for review in China.

The BLA for BAT1406 consists of a comprehensive data package that includes analytical, preclinical and clinical data. Clinical studies included a pharmacokinetic/pharmacodynamic (PK/PD) trial, and a Phase III confirmatory safety and efficacy study in ankylosing spondylitis.

Bio-Thera said it believes these data provide confirmation that the proposed biosimilar matches the reference medicine in terms of safety, efficacy and quality.

The company is developing several additional proposed biosimilars, including a biosimilar version of Avastin2, which is currently being evaluated in a global Phase III clinical trial.

Bio-Thera Solutions is also pursuing biosimilar versions of Actemra3/RoActemra4, Stelara5, Cosentyx6 and Simponi7.

Bio-Thera Solutions is a biotechnology company in Guangzhou, China. It is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases.

A specialist in next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and has applied for marketing authorization for one candidate.

In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases.
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