Biogen and Samsung's Enbrel biosimilar wins EMA nod for EU approval

Enbrel is one of the world's best-selling drugs with nearly $9 billion in global sales last year shared by Pfizer ($PFE) in Europe and Amgen ($AMGN) in the U.S. But competition is hot on its heels in the guise of biosimilars. And in the newest attack, a copycat version of the anti-TNF med from Biogen ($BIIB) and Samsung has been recommended for approval in Europe.

The European Medicines Agency today recommended the Samsung Bioepis drug, named Benepali, for approval by the European Commission, which usually acts favorably on the recommendations within a few months. This would be the first biosimilar of the drug in Europe.

The recommendation comes less than two months after Novartis' ($NVS) Sandoz had its biosimilar of Enbrel accepted for consideration by the FDA. Merck ($MRK) and Samsung recently won approval for a version of the rheumatoid arthritis and psoriasis treatment in South Korea and Cipla has a version in India.

The next couple of years look to be a watershed moment for biosimilars as a wave of the copies of biologics drugs test the world's acceptance. Initially, the line of reasoning was that they would be discounted only about 20% to 30% to the cost of the originator drugs, promising good returns for developers, without necessarily devastating sales of the branded drugs. There have also been questions about whether providers would be accepting.

But early indications in Europe have turned that theory on its head where a biosimilar of blockbuster Remicade from Pfizer's new unit Hospira and South Korea's Celltrion has sucked up significant market share. Merck ($MRK), which sells the arthritis drug in Europe, has reported that discounts of the biosimilar have averaged 45% there. They hit nearly 70% in Norway when Hospira and a drug distributor got into a pricing battle over public contracts. Merck recently offered discounts amounting to about 25% to the U.K.'s National Health Service to better compete with the Pfizer biosimilar there.

Rather than let the generics companies have all of this business to themselves, many of the Big Pharma players have found a way into biosimilar development one way or another. For its part Biogen is working with Samsung on others, including copies of Herceptin and Avastin, two Roche ($RHHBY) cancer drug blockbusters. The company believes its reputation for making quality branded biologics is going to be one of its calling cards in the lucrative market.

"These biosimilars will have the Biogen stamp of quality," Alpna Seth, head of the company's biosimilars business, told Bloomberg. "We aren't just dipping our toes in the water," Seth said. "We jumped in a long time ago into the deep end of the pool."

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Special Report: The 10 best-selling drugs of 2013 - Enbrel