- 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