“Bio-Thera is proud to file the first BLA for a proposed Humira biosimilar in China. 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,” said Shengfeng Li, CEO of Bio-Thera Solutions, in a statement.
The application submitted to CNDA includes a comprehensive data package that consists of analytical, preclinical, and clinical data. The clinical studies included a trial that investigated pharmacokinetic and pharmacodynamic data, as well as a phase 3 confirmatory study that investigated the safety and efficacy of the product in the treatment of ankylosing spondylitis. Bio-Thera says that it “believes these data provide confirmation that the proposed biosimilar matches the reference medicine in terms of safety, efficacy, and quality.”
BAT1406 references Humira, which is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis. Humira, the world’s top-selling drug, earned developer AbbVie $18.4 billion in global sales in 2017.
The drug, which makes up two-thirds of AbbVie’s overall sales, is forecast to bring in nearly $21 billion by 2020, according to a Reuters report. In the United States, there are currently 2 FDA-approved adalimumab biosimilars, to be marketed as Cyltezo and Amjevita, though the products are not currently available, and Amjevita is not slated to launch until 2023.
Bio-Thera also reports that its pipeline contains biosimilar candidates of bevacizumab, which is currently being investigated in a global phase 3 clinical trial, as well as tocilizumab, ustekinumab, secukinumab, and golimumab.