Samsung Bioepis gets Korean OK for Brenzys and Renflexis biosimilars

Samsung Bioepis said South Korean regulators have approved the country's first "self-developed" biosimilar with sales approved of the company's Brenzys, a copy of Amgen ($AMGN) and Pfizer's ($PFE) rheumatoid arthritis drug Enbrel and its Renflexis drug, a biosimilar of another arthritis treatment, Remicade.

The approval of Brenzys in South Korea "represents the first product approval under Merck's ($MRK) collaboration with Samsung Bioepis," the company said in a release, adding that Merck plans to release Brenzys in South Korea by the end of the year or in early 2016.

"The approval of Brenzys in Korea is a key milestone in Merck's longstanding commitment to improving access to important medicines," Dora Bibila, general manager of Merck Biosimilars, said in the release.

The company also said Merck's launch of Brenzys will include "comprehensive education and support services" for doctors, patients and caregivers.

Samsung Bioepis CEO Christopher Ko

"With an extensive pipeline of biosimilars on the way, we will continue to leverage our strengths in product development and quality assurance to bring these life-enhancing medications to patients who need them most," Christopher Hansung Ko, president and CEO of Samsung Bioepis, said in a release.

Samsung Bioepis said it is "solely responsible for the development of all immunology and oncology biosimilars in its pipeline" and is also responsible for global clinical trials and regulatory registration in all global markets.

- here's the release
- here's a story from the Korea Herald