KENILWORTH, N.J., and SEOUL, South Korea, June 10, 2015 – Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd. today 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 percent 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 will be 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, CEO 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 latestage 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.”
These two randomized, double-blind, parallel group, multicenter studies evaluated 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 U.S. 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 percent (193/247) in the SB4 arm vs. 80.3 percent (188/234) in the Enbrel arm. The adjusted rate difference was −2.22 percent (95 percent confidence interval, −9.41 percent to 4.98 percent), which was within the predefined margin (−15 percent, 15 percent).
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 percent (148/231) in the SB2 arm vs. 66.0 percent (163/247) in the Remicade arm. The adjusted rate difference was −1.88 percent (95 percent confidence interval, −10.26 percent to 6.51 percent), which was within the pre-defined margin (−15 percent, 15 percent).
Results of these three randomized, single-blind, three-arm, parallel group Phase 1 studies of SB4, SB2 and SB5 demonstrated the pharmacokinetic (PK) equivalence of each biosimilar candidate to its respective originator product sourced in the U.S. and in the EU. Each of these studies also demonstrated the PK equivalence of the U.S. 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.
A Phase III, Randomised, Double-blind Clinical Study Comparing SB4, an Etanercept Biosimilar, with Etanercept Reference Product (Enbrel) in Patients with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy (FRI0128); 12 p.m. CET, Friday, June 12, Hall 6
A Randomised, Double-blind, Phase III Study Comparing SB2, An Infliximab Biosimilar, To The Infliximab Reference Product (Remicade) In Patients With Moderate To Severe Rheumatoid Arthritis Despite Methotrexate Therapy (SAT0152); 10:15 a.m. CET, Saturday, June 13, Hall 6
A Phase I Pharmacokinetic Study Comparing SB4, an Etanercept Biosimilar, and Etanercept Reference Product (Enbrel) In Healthy Male Subjects (SAT0176); 10:15 a.m. CET, Saturday, June 13, Hall 6
A Phase I Pharmacokinetic Study Comparing SB2, an Infliximab Biosimilar, and Infliximab Reference Product (Remicade) In Healthy Subjects (SAT0144); 10:15 a.m. CET, Saturday, June 13, Hall 6
A Phase I Pharmacokinetic Study Comparing SB5, An Adalimumab Biosimilar, and Adalimumab Reference Product (Humira) in Healthy Subjects (FRI0110); 12 p.m. CET, Friday, June 12, Hall 6
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]:
Each of these five biosimilar candidates is expected to be filed with regulatory authorities around the world between 2015 and 2016.
The company 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. The company aims to be the world leading biopharmaceutical company with its heritage of innovation and advanced technologies. Please visit www.samsungbioepis.com for more information.
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Samsung Bioepis Announces Positive Top-Line Results from a Phase 3 Study Evaluating the Efficacy of Biosimilar Candidate SB5 Compared With Adalimumab In Patients With Moderate to Severe Rheumatoid Arthritis