Biocon and Mylan Report the US FDA Acceptance of BLA for Proposed Biosimilar of Avastin (bevacizumab)

 Biocon and Mylan Report the US FDA Acceptance of BLA for Proposed Biosimilar of Avastin (bevacizumab)

Biocon and Mylan Report the US FDA Acceptance of BLA for Proposed Biosimilar of AvasBiocon and Mylan Report the US FDA Acceptance of BLA for Proposed Biosimilar of Avastin (bevacizumab)tin (bevacizumab)

Shots:

  • The US FDA has accepted the BLA for Mylan’s MYL-1402O, a proposed biosimilar to Avastin (bevacizumab) for review under the 351(k)pathway with its anticipated BsUFA date as Dec 27, 2020
  • The BLA is based on P-III study assessing proposed biosimilar bevacizumab vs Avastin along with CT for 18wks. in 671 patients with stage 4 non-sq. NSCLC, after which patients continued to monothx. until 42wks. The P-III study resulted in meeting its 1EPs @18wks.
  • The companies anticipate approval of MYL-14020 + fluorouracil-based CT as 1L & 2L treatment for m-CRC and as a 1L treatment in combination with interferon alfa for non-sq. NSCLC, recurrent glioblastoma, m-RCC and persistent, recurrent or metastatic cervical cancer

Click here ­to­ read full press release/ article | Ref: Biocon | Image: Pinterest

Tuba Khan

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 tuba@pharmashots.com

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