Bio-Thera Solutions Reports the US FDA’s Acceptance of BLA for BAT1706 (Proposed Biosimilar to Avastin)

January 29, 2021 Auto Bot Acceptance, Avastin, Biosimilar, Biosimilars, BLA, FDA, reports 0

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

Click here ­to­ read full press release/ article | Ref: Business Wire | Image: Business Wire

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