Bio-Thera Solutions, a Chinese-based biotechnology company, says that the China National Drug Administration has accepted its Biologics License Application for a potential adalimumab biosimilar, BAT1406. This is the first proposed adalimumab biosimilar to be accepted for review in China.
Bio-Thera Solutions, a Chinese-based biotechnology company, recently announced that the China National Drug Administration (CNDA) has accepted its Biologics License Application (BLA) for a potential adalimumab biosimilar, BAT1406. This is the first proposed adalimumab biosimilar to be accepted for review in China.
Click here to read more about other adalimumab biosimilars in the global pipeline.
“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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.