Shots:

• The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy- safety- and immunogenicity. The anticipated BsUFA date is Nov 27- 2021
• The BLA seeks approval of BAT1706 for mCC in combination with fluorouracil-based CT- 1L treatment for nsq. NSCLC- recurrent glioblastoma- mRCC in combination with interferon alfa and persistent- recurrent or metastatic cervical cancer
• The FDA’s acceptance brings Bio-Thera closer to providing cancer patients in the US with a high-quality- low-cost treatment option

 ­ Ref: Business Wire | Image: Biothera