Merck, a global healthcare leader, and Samsung Bioepis Co. Ltd. announced that pivotal phase 3 clinical studies of SB4, an investigational biosimilar of Enbrel (etanercept), and SB2, an investigational biosimilar of Remicade (infliximab), met their primary endpoints, demonstrating equivalence to the originator medicine in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy.
The primary endpoint in the two studies was the American College of Rheumatology 20 per cent response criteria (ACR20), at week 24 and at week 30 of treatment, respectively. In these studies, SB4 and SB2 demonstrated a safety profile equivalent to the originator medicines.
These results are being presented for the first time at the European League Against Rheumatism (EULAR) 16th annual meeting in Rome, June 10-13.
“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 Christopher Hansung Ko, chief executive officer of Samsung Bioepis.
“As part of our collaboration with Merck, we currently have five biosimilar candidates, including SB5, an adalimumab biosimilar, in our late-stage development pipeline.”
“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 Biosimilars 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.”
Samsung Bioepis conducted two randomized, double-blind, parallel group, multicenter studies evaluating the efficacy, safety, pharmacokinetics and immunogenicity of SB4 biosimilar etanercept and SB2 biosimilar infliximab compared to originator Enbrel and Remicade, respectively, in adult patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Enbrel and Remicade are TNF inhibitors approved in the US and many other countries for the treatment of rheumatoid arthritis and certain other indications.
In the SB4 biosimilar etanercept study, 596 patients were randomized at 70 sites in 10 countries. In this study, SB4 was shown to be equivalent to Enbrel in terms of ACR20 response rate at week 24 of treatment in the per-protocol set: 78.1 per cent (193/247) in the SB4 arm vs. 80.3 per cent (188/234) in the Enbrel arm. The adjusted rate difference was -2.22 per cent (95 per cent confidence interval, -9.41 per cent to 4.98 per cent), which was within the pre-defined margin (-15 per cent, 15 per cent).
In the SB2 biosimilar infliximab study, 584 patients were randomized at 73 sites in 11 countries. In this study, SB2 was shown to be equivalent to Remicade in terms of ACR20 response rate at week 30 of treatment in the per-protocol set: 64.1 per cent (148/231) in the SB2 arm vs. 66.0 per cent (163/247) in the Remicade arm. The adjusted rate difference was -1.88 percent (95 per cent confidence interval, -10.26 per cent to 6.51 per cent), which was within the pre-defined margin (-15 per cent, 15 per cent).
Samsung Bioepis presented results of these three randomized, single-blind, three-arm, parallel group phase 1 studies of SB4, SB2 and SB5 demonstrating the pharmacokinetic (PK) equivalence of each biosimilar candidate to its respective originator product sourced in the US and in the EU. Each of these studies also demonstrated the PK equivalence of the US and EU sourced originator products. An equivalent safety profile to the originator product was demonstrated for each of the three biosimilar products in each of the three studies.
Merck and Samsung Bioepis announced in February 2013 a collaboration to develop and commercialize in certain partnered territories multiple biosimilar candidates. In February 2014, the two companies expanded the collaboration to include MK-1293, an insulin glargine biosimilar candidate currently in phase 3 clinical development for the treatment of patients with type 1 and type 2 diabetes. Under terms of the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration, except for MK-1293, which Merck will continue to develop and manufacture. Merck will be responsible in its partnered territories for commercialization of all approved products resulting from the collaboration.
The portfolio includes biosimilar candidates in immunology, oncology and diabetes. There are five candidates in phase 3 development [Merck partnered territories]: SB4 Enbrel (etanercept) [worldwide ex-U.S./EU/Japan], SB2 Remicade (infliximab) [worldwide ex-EU/Russia/Turkey], SB5 Humira (adalimumab) [worldwide ex-EU/Russia/Turkey], SB3 Herceptin (trastuzumab) [worldwide], MK-1293 Lantus (insulin glargine) [worldwide]
Each of these five biosimilar candidates is expected to be filed with regulatory authorities around the world between 2015 and 2016.
Samsung Bioepis was established in 2012 as part of the Samsung group, with the mission to produce affordable, high-quality biopharmaceutical products for many patients in need.