28 January 2021 - - The US Food and Drug Administration has accepted China-based biopharmaceutical company Bio-Thera Solutions' (SHA: 688177) Biologics License Application for BAT1706, a proposed biosimilar to Avastin (bevacizumab), the company said.

The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is November 27, 2021.

The BLA seeks approval of BAT1706 for the following indications treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, first-line treatment for patients with non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa and, persistent, recurrent or metastatic cervical cancer.

The BLA submission is based on data from a series of preclinical comparison studies, clinical pharmacokinetic comparison studies, and an international multi-center Phase III clinical comparison study that demonstrated that BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity.

Biosimilarity has not yet been established by any regulatory authorities.

BAT1706 is Bio-Thera Solutions' second proposed biosimilar submitted for regulatory approval.

The company's first biosimilar product, QLETLI, a biosimilar to Humira (adalimumab), has received marketing authorization and is available in China. Bio-Thera Solutions is developing several additional proposed biosimilars, including tocilizumab, golimumab, ustekinumab and secukinumab, and mepolizumab among others.

Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases.

As a leader in the next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and one of which, QLETLI, a biosimilar to Humira (adalimumab), is available to patients with rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, Crohn's disease and uveitis indications in China.

In addition, the company has multiple candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases.