Reuters logo
6 months ago
BRIEF-India's Biocon says USFDA accepts BLA for Mylan & co's proposed biosimilar Pegfilgrastim
February 16, 2017 / 1:09 PM / 6 months ago

BRIEF-India's Biocon says USFDA accepts BLA for Mylan & co's proposed biosimilar Pegfilgrastim

Feb 16 (Reuters) - Biocon Ltd :

* Says U.S. FDA accepts Biologics License Application (BLA) for Mylan and Biocon's proposed biosimilar Pegfilgrastim for review

* Proposed biosimilar to Neulasta is used to reduce duration of neutropenia and incidence of fever associated with neutropenia in adults

* Says FDA goal date set under Biosimilar User Fee Act is Oct 9, 2017 Source text: bit.ly/2llg560 Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below