Mylan, Biocon’s Breast Cancer Biosim Gets Extension

Aug. 31, 2017

The U.S. FDA granted Mylan Pharmaceuticals Pvt. and Biocon a three-month extension to get their approvals for selling a biosimilar of a Roche breast cancer drug, according to a Bloomberg article. FDA told Mylan it will extend the target action date for the Trastuzumab drug application to Dec. 3, 2017.

The extension resulted from a European drug regulator requesting Biocon to withdraw applications for Trastuzumab and Pegfilgrastim until the company completed requirements of a re-inspection of its manufacturing plant in Bengaluru, India, the story said. Earlier this month, the U.S. FDA had also found 10 quality offenses at the Bengaluru plant.

Read the Bloomberg article