Eye on Pharma: Bio-Thera Initiates Phase 1 Trial of Potential Tocilizumab Biosimilar

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, recently announced that it has initiated a phase 1 clinical trial for BAT1806, a proposed tocilizumab (Actemra) biosimilar. Last year, the reference Actemra brought in around $1.9 million for its sponsor, Roche.

Tocilizumab is an interleukin-6 inhibitor that can treat patients with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to 1 or more disease-modifying anti-rheumatic drugs (DMARDs). In addition, tocilizumab is also indicated to treat giant cell arteritis in adult patients, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

In this phase 1, randomized, double-blind, 3-arm, parallel group, single-dose trial, researchers are seeking to enroll around 130 participants. The study will compare the safety and pharmacokinetics of BAT1806 with that of the reference product. According to Bio-Thera’s website, a preclinical study found the efficacy and safety of BAT1806 to be consistent with the reference product.

“Initiating our phase 1 clinical trial for BAT1806, our proposed biosimilar for Actemra, is an important step for Bio-Thera as we work to develop and commercialize safe and effective biosimilars in China, the [European Union], the United States, and the rest of the world,” said Shengfeng Li, CEO of Bio-Thera Solutions, in a statement.

Some studies have also found that tocilizumab may be more efficacious than anti—tumor necrosis factor (anti-TNF) agents in patients with RA; one recent study compared the efficacy of tocilizumab and anti-TNF drugs as monotherapies or in combination with conventional synthetic DMARDs in patients with RA after the use of at least 1 biologic DMARD. The study investigators found that tocilizumab as a monotherapy and in combination therapy led significantly longer drug retention versus monotherapy or combination therapy with anti-TNF agents.

In addition to its work on tocilizumab, Bio-Thera reports that it is in the process of developing a number of other biosimilars, including bevacizumab (Avastin) which is currently being investigated in a global phase 3 clinical trial. Other proposed biosimilars under clinical investigation in the company’s pipeline are adalimumab (Humira), ustekinumab (Stelara), secukinumab (Cosentyx), and goliumab (Simponi).

Reference

Lauper K, Nordstrom D, Pavelka K, et al. Comparative effectiveness of tocilizumab versus TNF inhibitors as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis after the use of at least one biologic disease-modifying antirheumatic drug: analyses from the pan-European TOCERRA register collaboration [Published online May 5, 2018]. Ann Rheum Dis. http://dx.doi.org/10.1136/annrheumdis-2017-212845.