Today, Merck and Samsung Bioepis Co. announced that their biosimilar versions of the blockbuster anti-inflammatory drugs Enbrel and Remicade met their primary endpoints in late-stage studies.
The companies said that Phase III studies of SB4, an investigational biosimilar of Enbrel (etanercept), and SB2, an investigational biosimilar of Remicade (infliximab), met their main goals, demonstrating equivalence to the originator medicine in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy. The primary endpoints of both studies was the American College of Rheumatology 20 percent response criteria (ACR20), at week 24 and at week 30 of treatment, respectively.
In a 596-patient study, SB4 was shown to be equivalent to Amgen’s Enbrel in terms of ACR20 response rate at week 24 of treatment. SB4 elicited a 78.1 percent response rate versus Enbrel’s 80.3 percent response. In the SB2 biosimilar infliximab study, consisting of 584 patients, SB2 demonstrated to be equivalent to Johnson & Johnson’s Remicade in terms of ACR20 response rate at week 30 of treatment. SB2 elicited a 64.1 percent response rate versus originator Remicade’s 66 percent response.
These results, scheduled for presentation at the European League Against Rheumatism (EULAR) annual meeting in Italy, will support regulatory submissions.
“We are excited by the positive results from these two pivotal, head-to-head equivalence studies, which are part of the robust data packages intended to support global regulatory filings for SB4 and SB2,” said Samsung Bioepis CEO Christopher Hansung Ko. “As part of our collaboration with Merck, we currently have five biosimilar candidates, including SB5, an adalimumab biosimilar, in our late-stage development pipeline.”
In 2013, Merck agreed to work with Samsung Bioepis, a joint venture between Samsung Biologics and Biogen. Under the agreement, Merck will be responsible in its partnered territories for commercialization of all approved products resulting from the collaboration.
“Our collaboration with Samsung Bioepis to develop and commercialize multiple biosimilar candidates in our partnered markets is making significant progress, with five late-stage biosimilar candidates expected to be filed with regulatory authorities around the world within the next two years,” said Dora Bibila, associate vice president, and general manager, Merck Biosimilar Business. “We are excited by the opportunity to leverage the extensive capabilities of our two companies in the emerging biosimilars marketplace to help meet the growing needs of patients and healthcare systems worldwide.”
Last updated: 6/10/15; 11:45am EST