Market Overview

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


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

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
Avastin® is a registered trademark of Genentech, Inc
Actemra® is a registered trademark of Genentech, Inc
RoActemra® is a registered trademark of Genentech, Inc
Stelara® is a registered trademark of Janssen Biotech, Inc
Cosentyx® is a registered trademark of Novartis
Pharmaceuticals Corporation
7 Simponi® is a registered
trademark of Janssen Biotech, Inc

View Comments and Join the Discussion!