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.