Bio-Thera Solutions (SHA: 688177), a commercial-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for BAT1706, a proposed biosimilar to Avastin® (bevacizumab). 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: 1) treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, 2) first-line treatment for patients with non-squamous non-small cell lung cancer, 3) recurrent glioblastoma, 4) metastatic renal cell carcinoma in combination with interferon alfa and, 5) persistent, recurrent or metastatic cervical cancer.
"The FDA's acceptance of our BLA is a significant achievement that brings Bio-Thera closer to providing cancer patients in the USA with a high-quality, low-cost treatment option," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. "Regulatory filings for BAT1706 have now been accepted by the China National Medical Products Administration (NMPA), European Medicines Agency (EMA) and FDA, demonstrating Bio-Thera's commitment to developing BAT1706 to global standards so that BAT1706 can be made available to the global cancer patient community."
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.
About Bio-Thera Solutions
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. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
Bio-Thera's Notes Regarding Forward-Looking Statements
This press release contains certain forward-looking statements relating to BAT1706 or Bio-Thera Solutions and its product pipeline in general. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "will," "would," "could," "may," "potential," "promising," "plans," "expected," or similar expressions. They reflect Bio-Thera Solutions' current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information available to Bio-Thera Solutions as of the date of this press release and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research, development and commercialization, such as the risks and uncertainties of pre-clinical and clinical studies, and in obtaining regulatory approvals. Other risk factors include risks and uncertainties in manufacturing, distribution, marketing, competition, intellectual property, product efficacy or safety, changes in national and global financial and healthcare situations, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise.
These press releases may also interest you