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news.Bio-Thera Solutions, a commercial-stage biopharmaceutical company, today announced that the Phase III clinical trial comparing the safety and efficacy of BAT1706 versus Avastin (bevacizumab) met its primary endpoint
Bio-Thera Solutions announces positive top-line results for BAT1706, a proposed biosimilar to Avastin. (Credit: PublicDomainPictures from Pixabay)
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BAT1706 is being developed by Bio-Thera Solutions as a proposed biosimilar to Avastin. The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer.
“We are pleased to report on our second proposed biosimilar with positive study results. These results demonstrate the potential of our proposed bevacizumab biosimilar to be a safe and effective treatment option for cancer patients,” said Shengfeng Li, Ph.D., CEO of Bio-Thera Solutions. “Bio-Thera is committed to increasing patient access to innovative medicines through the development of high-quality biosimilars.”
The BAT1706 Phase III clinical study is a multicenter, randomized, double blind, study evaluating the efficacy, safety, pharmacokinetics and immunogenicity of BAT1706 versus EU Avastin plus chemotherapy in patients with advanced non squamous non-small cell lung cancer. The primary endpoint measures ORR. Results of the study will be presented in full at a future medical meeting or summarized in publication.
BAT1706 is Bio-Thera Solutions’ second proposed biosimilar with positive Phase III study results. The company’s first biosimilar product, QLETLI (格乐立), a biosimilar to Humira (adalimumab), has received marketing authorization and is available in China. Bio-Thera Solutions is developing several additional proposed biosimilars, including ustekinumab, secukinumab and golimumab, among others.
