Merck, Samsung biosimilars demonstrate equivalence in RA

Merck & Co. Inc. (NYSE:MRK) and partner Samsung Bioepis Co. Ltd. said their biosimilars of Enbrel etanercept and Remicade infliximab met the primary endpoint of equivalence to their reference products in separate head-to-head Phase III trials to treat moderate to severe rheumatoid arthritis.

The partners' SB4 showed equivalence to Enbrel as measured by ACR20 at week 24 among patients in the first study's per-protocol set, with 78.1% of those receiving SB4 achieving the endpoint compared to 80.3% for Enbrel. The partners' SB2 showed equivalence to Remicade as measured by ACR20 at week 30 in the second study's per-protocol set, with 64.1% of SB2-treated patients achieving the endpoint vs. 66% for Remicade. ...