Guangzhou-based biopharmaceutical company Bio-Thera Solutions recently announced that the China National Drug Administration has accepted for review the BLA for BAT1406, a proposed Humira® (adalimumab) biosimilar. Bio-Thera states that the BAT1406 BLA contains clinical data from a pharmacokinetic/pharmacodynamic (PK/PD) trial and a Phase III confirmatory safety and efficacy study in ankylosing spondylitis. According to Bio-Thera, this is the first BLA accepted for a proposed Humira® biosimilar in China.
In addition, Bio-Thera also recently announced that it has initiated a Phase I clinical trial to compare the pharmacokinetics and safety of BAT1806, a proposed biosimilar to US-sourced Actemra® and EU-sourced RoActemra® (toclizumab products marketed by Roche under different trade names in different regions). According to the press release, the trial is “a randomized, double-blind, three-arm, parallel group, single-dose study that is expected to enroll approximately 130 healthy volunteers,” and marks “an important step for Bio-Thera as [it] work[s] to develop and commercialize safe and effective biosimilars in China, the EU, the US and the rest of the world[.]” Actemra® (toclizumab) is approved in the U.S. to treat rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome. Based on sales data reported by Roche, Actemra®/ RoActemra® generated 2017 sales of about $1.9 billion worldwide and about $750 million in the U.S.