China’s Bio-Thera has announced the start of a phase I clinical trial for its copy biological of golimumab, which is currently marketed by Janssen Biotech as Simponi. The trial will include over 180 healthy volunteers and aims to assess the pharmacokinetics and safety of the biosimilar (BAT2506). Each volunteer will receive a single dose of BAT2506 or Simponi in the double-blind trial.

The CEO of Bio-Thera Shengfeng Li said, ‘Initiating our Phase I clinical trial for BAT2506, our proposed copy biological for Simponi, represents the fourth copy biological that Bio-Thera has advanced into clinical trials.’

In other good news for the company, Bio-Thera’s adalimumab copy biological (BAT1406) has met its primary endpoint of equivalent efficacy to the reference product (AbbVie’s Humira) in a phase III trial. The treatment is a monoclonal antibody used to treat various forms of arthritis and other inflammatory conditions. The trial was conducted in China among 554 patients with active ankylosing spondylitis, a type of arthritis associated with inflammation of the spine.

In the randomized trial, 363 patients received the copy biological and 191 received the reference product. By Week 12 of the study, 75.7% of copy biological patients had shown an absolute improvement of at least 10 units, compared to 73.7% of the reference-treated patients. The frequency of adverse events between the copy biological and reference arm was also similar.

Bio-Thera has submitted an application for BAT1406 to China’s regulatory body and expects to be the first copy biological adalimumab approved in the country. The application includes a comprehensive data package including additional analytical, preclinical and clinical (including pharmacokinetic and pharmacodynamic) data.

A Bio-Thera representative said, ‘these data provide confirmation that the proposed copy biological matches the reference medicine in terms of safety, efficacy and quality.’

Bio-Thera is also developing copy biological of bevacizumab and tocilizumab (currently marketed as Avastin and Actemra, respectively, both of which are currently being investigated in phase III trials) and ustekinumab (Stelara).

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