Merck, Samsung Get Biosimilar Approval in Korea

Merck & Co. Inc. and Samsung Bioepis Co., have received 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 treating 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 biosimilars collaboration with Samsung Bioepis. Merck plans to launch Brenzys in South Korea by the end of this year or early next year.

The approval of Brenzys in Korea was supported by rigorous analytical structural and functional testing, as well as a Phase I crossover pharmacokinetics study and a Phase III clinical study comparing Brenzys to the originator medicine.

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, reference product, Enbrel (etanercept) (worldwide ex-U.S./EU/Japan); SB2, reference product, Remicade (infliximab) (worldwide ex-EU/Russia/Turkey); SB5, reference product, Humira (adalimumab) (worldwide ex-EU/Russia/Turkey); SB3, reference product, Herceptin (trastuzumab) (worldwide); and MK-1293, reference product, Lantus (insulin glargine) (worldwide). Additional regulatory filings for each of these five biosimilar candidates are expected to occur in the 2015-2016 timeframe.

Source: Merck & Co.

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