Merck & Co. Advances Biosimilar Candidates
Merck & Co. and Samsung Bioepis will present new Phase III 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, being held November 7 to November 11. Merck and Samsung Bioepis have a collaborative agreement to develop and commercialize biosimilar candidates in immunology, oncology, and diabetes.
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 III clinical development for the treatment of patients with Type 1 and Type 2 diabetes. Under 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 III development [Merck partnered territories]: SB4, a bisimilar for Enbrel (etanercept) [worldwide ex-U.S./EU/Japan]; SB2, a biosimilar for Remicade (infliximab) [worldwide ex-EU/Russia/Turkey]; SB5, a biosimilar for Humira (adalimumab) [worldwide ex-EU/Russia/Turkey]; SB3, a bisimilar for Herceptin (trastuzumab) [worldwide]; and MK-1293, a biosimilar for 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 time frame.
In September, SB4, a biosimilar for Enbrel (etanercept), 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, Merck will market SB4 in Korea under the brand name Brenzys (etanercept).
At the ACR and ARHP conferences, Merck will be presenting data on SB4, its biosimilar candidate for Enbrel (etanercept); SB2, its biosimilar candidate for Remicade (infliximab); and SB5, its biosimilar candiate for Humira (adalimumab).
Source: Merck & Co.