BioCentury
ARTICLE | Clinical News

Mylan/Biocon biosimilar shows equivalence to Herceptin

June 4, 2016 12:18 AM UTC

Mylan Inc. (NASDAQ:MYL) and partner Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said Myl-1401O, their biosimilar of Herceptin trastuzumab, met the primary endpoint of bioequivalence to its reference product in the Phase III HERITAGE study, which compared the compounds as first-line therapies for HER2-positive metastatic breast cancer.

On an earnings call last month, Mylan President Rajiv Malik said the company expects to submit a regulatory application to FDA for the biosimilar "in the next few months." Mylan did not respond to inquiries on Friday. ...