Samsung has agreed to set up a $300 million venture with Biogen Idec to develop, manufacture and market biosimilars. Samsung will take a leading role in the joint venture, with Biogen Idec contributing its expertise in protein engineering and biologics manufacturing.

Biogen will work with Samsung Biologics, a drug manufacturer established in April by Samsung Group companies and Quintiles Transnational. Samsung will contribute $255 million to own 85 percent of the joint venture while Biogen will contribute $45 million, for a 15 percent stake. The venture will be based in South Korea and will contract with both companies for technical development and manufacturing services. It will not pursue any biosimilars of Biogen’s proprietary products.

Biosimilars have become an area of enormous interest within the biopharmaceuticals industry, sparked by the amendment to the Public Health Service Act that created an abbreviated pathway for biologics that are demonstrated to be “biosimilar” to or “interchangeable” with a U.S. Food and Drug Administration licensed biological product.

Biological products can include a wide range of products including vaccines, gene therapies, tissues, and proteins. Unlike generic drugs, which are copies of small molecule drugs that are chemically synthesized, the molecular complexity of biologics and the fact that they are produced by living cells, means biosimilars are not truly identical to their branded counterparts.

To date, the FDA has not yet approved a biological product as “biosimilar.” There has been a growing interest to garner the first breakthrough biosimilar. Biogen CEO George Scangos had been keen to promote the prospects of biosimilars. In an interview with Reuters in May 2011, Scangos said that he believed a follow-on biologics business could gain more than a billion dollars a year in revenue and added that Biogen would be very interested in a partnership that allowed it to remain focused on manufacturing the drugs while the partner would handle clinical trials, commercialization, sales and marketing. That right partner was found in Samsung Biologics.

“This relationship will allow us to leverage our world-class protein engineering and biologics manufacturing capabilities while maintaining focus on our mission of discovering, developing and delivering innovative therapies,” said Scangos.

Burrill & Company, publisher of the Burrill Report, served as an advisor to Samsung in the agreement.

Editor's note: The original version of this story misidentfied George Scangos. It was corrected.