Posted by Michael Wonder on 19 Jan 2017
Boehringer Ingelheim biosimilar candidate to Humira accepted for EMA and FDA regulatory review
18 January 2017 - BI 695501 EMA and FDA applications are first biosimilar regulatory filings for Boehringer Ingelheim.
Boehringer Ingelheim announced today that BI 695501, its adalimumab biosimilar candidate to Humira, has been accepted for regulatory review by the EMA and the U.S FDA.
Top-line results from the completed Phase III study for BI 695501 in patients with active rheumatoid arthritis were announced on 26 October 2016.
