India markets open in 4 hours 13 minutes
  • BSE SENSEX

    52,306.08
    -282.63 (-0.54%)
     
  • Nifty 50

    15,686.95
    -85.80 (-0.54%)
     
  • Dow

    33,874.24
    -71.34 (-0.21%)
     
  • Nasdaq

    14,271.73
    +18.46 (+0.13%)
     
  • BTC-INR

    2,495,722.75
    +92,781.25 (+3.86%)
     
  • CMC Crypto 200

    800.68
    -9.51 (-1.17%)
     
  • Hang Seng

    28,817.07
    +507.31 (+1.79%)
     
  • Nikkei

    28,874.89
    -9.24 (-0.03%)
     
  • EUR/INR

    88.4631
    0.0000 (0.00%)
     
  • GBP/INR

    103.5103
    0.0000 (0.00%)
     
  • AED/INR

    20.1410
    0.0000 (0.00%)
     
  • INR/JPY

    1.4938
    0.0000 (0.00%)
     
  • SGD/INR

    55.0960
    0.0000 (0.00%)
     

Biocon slips after USFDA issues deferred action on Avastin biosimilar license application

·1-min read

Bevacizumab, sold under the brand name Avastin, is a medication used to treat a number of types of cancers and a specific eye disease.

Biocon Biologics (a subsidiary of Biocon) and Mylan (a subsidiary of Viatris Inc.) have been informed by the U.S. Food and Drug Administration (USFDA) of a deferred action on the Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab).

To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the standard review process. However, due to restrictions on travel related to COVID-19, the agency is unable to conduct an inspection during the current review cycle.

"We await the dates for the inspection. There are no additional observations related to the application," Biocon Biologics company spokesperson said in a statement.

Biocon is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune.

The company's consolidated net profit fell 23% to Rs 195.4 crore on 11.33% rise in net sales to Rs 1744.8 crore in Q2 September 2020 over Q2 September 2019.



Source: Capitalmarket.com

Our goal is to create a safe and engaging place for users to connect over interests and passions. In order to improve our community experience, we are temporarily suspending article commenting