China’s Bio-Thera begins trials to develop biosimilar to Actemra

By Maggie Lynch

- Last updated on GMT

(Image: Getty/VeranoVerde)
(Image: Getty/VeranoVerde)

Related tags Biosimilars Bio-Thera Actemra

A Phase I clinical trial to examine the safety and pharmacokinetics of BAT1806, an Actemra biosimilar, is to be conducted by Chinese pharmaceutical company Bio-Thera.

The trial will be conducted to examine BAT1806 against Actemra, also known as RoActemra in Europe. Actemra (tocilizumab) is an immunosuppressive often used to treat rheumatoid arthritis.

Bert Thomas, senior vice president of business development at Bio-Thera Solutions, explained to us: “The goal of this trial is to show that BAT1806 has similar pharmacokinetics and safety as Actemra in patients, which will be followed by a Phase 3 clinical trial to demonstrate that the proposed biosimilar has the same efficacy as Actemra.”

According to Thomas, biosimilars can provide a lower cost alternative to originator biologic drugs, much like generic drugs did for small molecule drugs in the past. Lower cost drugs mean that patients using the treatments incur a lower cost on healthcare systems and access for patients increase.

Thomas stated that clinical studies like this one can provide confidence to regulators, doctors, and patients. He believes that providing patients with the confidence that the lower cost drug they are given is as safe and effective as the originator is of the utmost importance.

According to a press release​ from Bio-Thera the trial will be a randomized, double-blind, three-arm, parallel group single dose study.

Bio-Thera is also conducting Phase III trials for a biosimilar to Avastin. They are also pursuing biosimilars for Humira, Stelara, Cosentx, and Simponi.

The FDA recently announced its Biosimilar Action Plan​, in order to stimulate biosimilar development and understanding of biosimilars among patients.

Related topics Bio Developments Biosimilars

Related news

Show more