Biogen Idec preps for a big leap into the anti-TNF blockbuster biosimilars market

Biogen Idec ($BIIB) is taking its supporting role in a big biosimilars development venture with Korea's Samsung one giant leap forward. The Big Biotech spread the word this morning that it will take the lead on commercializing their anti-TNF knockoffs for some big inflammatory targets--including rheumatoid arthritis and Crohn's disease--in Europe, where they plan to follow a regulatory trail that's already been clearly marked out.

Biogen originally inked its JV deal with Samsung--dubbed Samsung Bioepis--two years ago as CEO George Scangos kept a commitment to find a practical way to capitalize on the new market by leveraging the company's manufacturing and development know-how. The two companies have emerged as key players in the advancement of biologic follow-on products, though they have been quiet on exactly which drugs are in their sights.

The Korean conglomerate said initially that it planned to invest $2 billion in its new biosimilars venture, with Biogen Idec contributing a minority share of the initial $300 million down payment. Merck later jumped into the venture after experiencing some big setbacks in the field.

There's no word in the joint announcement today on exactly which anti-inflammatory blockbusters are on the table, but ClinicalTrials.gov flags a trial for SB2 from Samsung Bioepis in comparison with J&J's ($JNJ) Remicade along with another study of SB4 against Amgen's ($AMGN) Enbrel.

Europe has approved a number of biosimilars over recent years, but the market took a big step forward a few months ago when regulators on the continent approved Inflectra, a copycat of Remicade from Hospira ($HSP) and Celltrion. The pioneering move marked the entry of the first discounted biologic to go head-to-head with the original. Europe has moved well ahead of the U.S. on biosimilars, as the FDA has yet to fully clarify the regulatory pathway that will be established for approving biosimilars in the giant North American market. Nevertheless, Novartis ($NVS), Amgen and others have been advancing their own biosimilars in anticipation of creating a valuable new market for generic biologics.

"This is a unique opportunity for us to leverage our experience in developing and manufacturing high-quality biologics in therapeutic areas where we are deeply focused, and provide medicines to patients where there is a significant societal need," said Tony Kingsley, executive vice president of global commercial operations for Biogen Idec. "As a company that aims to make a difference in the lives of patients with serious diseases, we are excited by the potential to offer additional highly effective therapies in critical areas where there is growing demand."

- here's the press release

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