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

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

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

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: Business Wire

Click here to­ read the full press release 

Tuba

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on connect@pharmashots.com

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