Merck announced that Samsung Bioepis will present new phase 3 clinical data for three investigational immunology biosimilar candidates at the American College of Rheumatology (ACR) and the Association for Rheumatology Health Professionals (ARHP) 2015 Annual Meeting in San Francisco from November 7-11.
Merck and Samsung Bioepis have a collaborative agreement to develop and commercialize biosimilar candidates in immunology, oncology and diabetes. These products have been designed to help meet the growing needs of patients and healthcare systems worldwide. In September, SB4 was approved by the Ministry of Food and Drug Safety in Korea, representing the first biosimilar product approval for Samsung Bioepis. Under Merck’s partnership with Samsung Bioepis, MSD will market SB4 in Korea under the brand name BRENZYS (etanercept).
“Patients living with rheumatoid arthritis and other chronic inflammatory diseases are faced with many challenges,” said Dora Bibila, general manager, Merck Biosimilars. “Through our partnership with Samsung Bioepis, Merck is committed to commercializing biosimilar alternatives to existing biologic therapies, and we are excited by the opportunity to expand patient access to effective and more affordable treatment options.”
Merck and Samsung Bioepis announced in February 2013 a collaboration to develop and commercialise 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 commercialisation 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].
Regulatory filings for each of these five biosimilar candidates are expected to occur in the Merck partnered territories in the 2015-2016 timeframe.