Merck, a global healthcare leader, and Samsung Bioepis Co., Ltd., a part of the Samsung group, announced the approval of Brenzys (etanercept), a biosimilar of the immunology medicine Enbrel, by the Ministry of Food and Drug Safety (MFDS) in Korea. Brenzys is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis) and psoriasis in adult patients (age 18 years and older).
The approval of Brenzys in Korea represents the first product approval under Merck’s collaboration with Samsung Bioepis, which is designed to offer high-quality biosimilar alternatives to existing biologic medicines to help address patient and healthcare system needs worldwide. Merck plans to launch Brenzys in South Korea by the end of this year or early next year.
“We are very excited to receive this first regulatory approval of a biosimilar product resulting from our late-stage development pipeline,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “The approval of Brenzys in Korea is especially gratifying, and underscores our commitment to advancing healthcare through innovation and groundbreaking technology. We look forward to building on this progress in our collaboration with Merck.”
“The approval of Brenzys in Korea is a key milestone in Merck’s longstanding commitment to improving access to important medicines,” said Dora Bibila, general manager, Merck Biosimilars. “We are excited by the opportunity to deliver on the promise of biosimilars overall – and on the promise of Brenzys – by combining Merck’s deep global customer expertise with the extensive development and manufacturing capabilities of Samsung Bioepis.”
Merck’s launch of Brenzys will include comprehensive education and support services for healthcare professionals, patients and their caregivers, including biosimilars education, disease education, and reimbursement and access support.
The approval of Brenzys in Korea was supported by rigorous analytical structural and functional testing, as well as a phase 1 crossover pharmacokinetics study and a phase 3 clinical study comparing Brenzys to the originator medicine.
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 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].
Additional regulatory filings for each of these five biosimilar candidates are expected to occur in the 2015-2016 timeframe.