The Burrill Report


Biogen Idec is exercising its option to commercialize biosimilars with Samsung Bioepis in Europe to treat conditions such as rheumatoid arthritis and Crohn’s disease. If successful, the partners will produce therapeutics that could offer new cut-price competition for branded biologics from Janssen and Amgen.

Under the new agreement, Biogen and Bioepis plan to market an unspecified number of biosimilars targeting tumor necrosis factor, which is implicated in a variety of autoimmune diseases. Biogen will take responsibility for commercialization of product candidates across Europe, while Bioepis will handle manufacturing.

Tony Kingsley, Biogen's executive vice president of global commercial operations, called the agreement a unique opportunity to provide medicines to patients while addressing a significant societal need. The deal also offers a potentially unique growth prospect for Biogen and Samsung, which formed Bioepis in February 2012 to take advantage of the growing opportunity biosimilars may offer. IMS Health projects that by 2015, sales of biosimilars will reach between $1.9 billion and $2.6 billion globally, up from $378 million for the year from the second half of 2010 to the first half of 2011.

The partners are focusing on Europe because it has the most defined regulatory pathway for biosimilars review and approval. The European Commission approved Hospira’s Inflectra, Europe’s first biosimilar antibody for inflammatory diseases in September, creating competition for Janssen’s blockbuster Remicade. Amgen's blockbuster in the category, Enbrel, could face competition next, as Bioepis and Biogen compete against another biosimilars partnership targeting inflammation, a collaboration between Sandoz and Coherus Biosciences.

Biogen and Samsung are hedging their bets with biosimilars, by seeking not only to commercialize their own products, but also by working with competitors. In February, Bioepis struck a development and commercialization agreement with Merck.

Samsung Biologics, Biogen's partner in Bioepis, owns a $250 million, 85 percent stake in the company. Biogen owns the remaining 15 percent, for which it paid about $45 million. Should the venture prove attractive, however, Biogen retains an option to increase it ownership share to as much as to 49.9 percent—an option it could well take advantage of if the anti-TNF venture in Europe is a success.

December 18, 2013
http://www.burrillreport.com/article-biogen_and_samsung_to_market_biosimilars_in_europe.html