Korea Enbrel biosimilar approval a milestone for Merck and Samsung JV

By Dan Stanton

- Last updated on GMT

Korea's Ministry of Food and Drug Safety (MFDS) approves Merck and Samsung's Enbrel biosimilar
Korea's Ministry of Food and Drug Safety (MFDS) approves Merck and Samsung's Enbrel biosimilar

Related tags Samsung bioepis Etanercept Monoclonal antibodies Adalimumab

A copycat version of Amgen’s Enbrel has been approved in Korea, marking the first regulatory success for Merck & Co and Samsung Bioepis' biosimilar joint venture.

In 2012, Merck teamed up with Samsung Bioepis - the biomanufacturing subsidiary of tech giant Samsung formed through a $300m joint venture with Biogen Idec the year prior - to develop and commercialise a number of biosimilar products.

This week, the firms achieved their first approval under the JV, with the Ministry of Food and Drug Safety (MFDS) in Korea giving the nod to Brenzys, a version of Amgen’s arthritis TNF inhibitor Enbrel (etanercept).

The news was described as “a key milestone”​ by Merck, which is hoping to launch the product in Korea as early as the end of this year.

“Brenzys at launch will be manufactured at the Biogen manufacturing facilities, which are state-of-the-art biologics facilities located in Hillerod, Denmark,”​ spokesman for the Pharma Giant Robert Consalvo told Biopharma-Reporter.com. “This is also where the clinical trial materials were manufactured.”

But under terms of the agreement Samsung Bioepis is responsible for production of the product, and Consalvo said there are plans post-launch to transfer the manufacturing of Brenzys to a biologics facility in South Korea.

Samsung Bioepis, currently considering an initial public offering (IPO),​ is also responsible for regulatory filings and to date the firm has reported it has submitted filings for Brenzys in the EU and Canada, in addition to Korea.

There are five biosimilar candidates in Phase III development between the two firms, with versions of J&J’s Remicade (infliximab), AbbVie’s Humira (adalimumab) and Roche’s Herceptin (trastuzumab) complementing etanercept.

The fifth is a version of Sanofi’s insulin glargine product Lantus but Merck retains manufacturing responsibilities for this product.

Related topics Markets & Regulations Biosimilars

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