Merck and Samsung Bioepis presented multiple biosimilar clinical data

June 15, 2015 1:36 PM

Merck, and Samsung Bioepis 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.

Merck and Samsung Bioepis declared that, both products demonstrated 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 were presented 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.

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.

Under terms of the agreement between companies, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration, except for 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), 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.

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