Bio-Thera Solutions Announces China National Drug Administration Acceptance of Biologics License Application for Proposed Biosimilar to Humira® (Adalimumab)

GUANGZHOU, China--()--Bio-Thera Solutions, a global biopharmaceutical company today announced that the China National Drug Administration (CNDA) has accepted for review the Biologics License Application (BLA) for BAT1406, a proposed biosimilar to Humira®1 (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. The BLA for BAT1406 is the first BLA for a proposed adalimumab biosimilar accepted for review in China.

“Bio-Thera is proud to file the first BLA for a proposed Humira biosimilar in China,” said Shengfeng Li, Chief Executive Officer of Bio-Thera Solutions. “We expect BAT1406 to be the first Humira biosimilar to be approved for the China market, allowing more patients to have access to an important autoimmune therapy at a more affordable cost.”

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

Bio-Thera Solutions is developing several additional proposed biosimilars, including a biosimilar version of Avastin®2, which is currently being evaluated in a global Phase III clinical trial. Bio-Thera Solutions is also pursuing biosimilar versions of Actemra®3/RoActemra®4, Stelara®5, Cosentyx®6 and Simponi®7.

About Bio-Thera Solutions

Bio-Thera Solutions Ltd, a leading global biotechnology company in Guangzhou, China, 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 leader 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. For more information, please visit or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).

1 Humira® is a registered trademark of Abbvie, Inc
2 Avastin® is a registered trademark of Genentech, Inc
3 Actemra® is a registered trademark of Genentech, Inc
4 RoActemra® is a registered trademark of Genentech, Inc
5 Stelara® is a registered trademark of Janssen Biotech, Inc
6 Cosentyx® is a registered trademark of Novartis Pharmaceuticals Corporation
7 Simponi® is a registered trademark of Janssen Biotech, Inc


Bio-Thera Solutions, Ltd:
Bert E. Thomas IV +1-410-627-1734

Release Summary

Bio-Thera Solutions announces the acceptance of the BLA for BAT1406, a proposed Humira (adalimumab) biosimilar, by the China New Drug Administration.


Bio-Thera Solutions, Ltd:
Bert E. Thomas IV +1-410-627-1734