On January 28, 2021 Bio-Thera Solutions (SHA: 688177), a commercial-stage biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for BAT1706, a proposed biosimilar to Avastin (bevacizumab) (Press release, BioThera Solutions, JAN 28, 2021, View Source [SID1234574388]). The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is November 27, 2021.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 (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 tocilizumab, golimumab, ustekinumab and secukinumab, and mepolizumab among others.