Merck/Samsung Bioepis win their 1st biosim approval in Korea—for copycat Enbrel
- The approval of Brenzys, a biosimilar version of Amgen's psoriasis med Enbrel, in Korea is the first product approval for the Merck/Samsung Bioepis development team, which is working on biosimilar versions of at least five major drugs.
- Enbrel is used to treat rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis), and plaque psoriasis in adult patients.
- Merck plans to launch Brenzys in South Korea by the end of this year, or in early 2016.
Merck and Samsung Bioepis are emerging as the dynamic duo of biosimilar development. In addition to being the first approved product from this team, Brenzys is also the first Enbrel biosimlar to undergo regulatory review in the E.U.
It was clear in June that Brenzys had a good shot when Merck unveiled phase III clinical trial data. In a randomized, double-blind study, Brenzys demonstrated equivalence to Enbrel in terms of the American College of Rheumatology 20 percent (ACR20) response rate at weeks 24 and 30, respectively. In this trial, Brenzys elicited a 78.1% response rate versus Enbrel's 80.3% response.
Brenzys is now available in Korea as a high-quality, biosimilar option for Enbrel, which generated $8.4 billion in revenues for Amgen in 2014. In order to support its drug, Merck will provide comprehensive education and support services for physicians, patients and caregivers, as well as reimbursement support.
As BioPharma Dive has previously reported, Merck and Samsung are collaborating on biosimilars of five of the best-selling biologics in the world: Enbrel, J&J's Remicade, AbbVie's Humira, Roche/Genentech's Herceptin, and Sanofi's Lantus. Those products are all in phase III development and are expected to be filed for regulatory approval around the world between 2015 and 2016.
There's also been whispers that Samsung may be getting ready to spin off Samsung Bioepis into its own entity in a deal with Biogen that would involve a $1 billion IPO. The Merck collaboration—and the future of Samsung Bioepis—is something to keep an eye on as biosimilars penetrate a larger share of the market.