Bio-Thera Begins Phase 3 Trial of Proposed Tocilizumab Biosimilar

Bio-Thera Solutions, a China-based biosimilar developer, announced that it has dosed the first patients in its phase 3 clinical study of BAT1806, a proposed biosimilar tocilizumab referencing Actemra, an interleukin-6 inhibitor.

The trial will compare the safety and efficacy of the biosimilar with those of the reference product in patients with rheumatoid arthritis (RA). Bio-Thera plans to enroll 600 patients at more than 45 sites worldwide and says that results of the study are expected in the second half of 2020. In 2021, the company plans to file for regulatory approval in the United States, the European Union, and China.

“Patient enrollment in our phase 3 clinical trial for BAT1806 is another important step as Bio-Thera works to develop and commercialize a pipeline of safe, effective and affordable biosimilars,” said Shengfeng Li, chief executive officer of Bio-Thera Solutions, in a statement.

The company previously announced its phase 1 trial for BAT1806 in July 2018, with the goal of comparing the safety and pharmacokinetics (PK) of the biosimilar with those of the reference.

To date, no tocilizumab biosimilars are approved in highly regulated territories, but multiple developers are targeting the drug. Earlier this month, Mycenax announced positive phase 1 PK, safety, and tolerability data for its proposed biosimilar.

Mycenax says that it plans to apply for scientific advice from the European Medicines Agency and Japan’s Medical Devices Agency in the first quarter of 2019 to finalize its phase 3 study design. The company has indicated that it hopes to secure eventual approval for both intravenous and subcutaneous dosage forms of the biosimilar.

In addition to RA, tocilizumab is also indicated to treat giant cell arteritis in adult patients, polyarticular juvenile idiopathic arthritis, and juvenile idiopathic arthritis. Some data have shown that patients who achieve low disease activity while taking tocilizumab may be able to discontinue methotrexate without worsening disease activity, which is a welcome finding for patients who have adverse events related to concomitant methotrexate therapy.