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Biosimilars face big delays as blockbuster knockoffs hit a roadblock

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The news on the biosimilar R&D front has been all bad in recent months--at least for the biggest players in the business. Merck ($MRK), Teva ($TEVA) and Samsung have all experienced severe setbacks, scrapping follow-on programs for some of the biggest biologic targets now on the market. 

The Wall Street Journal assessed the situation and concluded that the nascent business of biosimilars will not develop as quickly as analysts had expected even a year ago. And the new timelines could well prove that some of these mega-earners won't face cheaper competition for years--adding billions more to the franchise value of these therapies. 

"There are emerging signs of a shakeout in biosimilars, and only the strong will survive," Jeff George, division head for Novartis AG's Sandoz generics unit, tells the Journal.

"There has been a little bit of volatility" in biosimilar efforts, noted Richard Murray, vice president of Merck's biologics and vaccines unit. Just days ago Merck abandoned its initial effort and restructured around a marketing pact with Samsung and its biotech partner Biogen Idec ($BIIB).

"It's going to be a difficult market for new competitors to enter," said AbbVie ($ABBV) CEO Richard Gonzalez, who depends heavily on Humira's massive earning power. 

The Journal's article focused heavily on the scientific complexity involved in developing a biologic, but the patent attorneys seem to be equally influential, if not more so. Merck had to give up on the Enbrel knockoff because Amgen ($AMGN) pulled off a patent surprise. And AbbVie says it will fight to defend all 200 patents tied to Humira.

For now, it seems that the pathway on biosimilars is primarily open only in Europe, with the U.S. years behind schedule.    

- here's the article from The Wall Street Journal (sub. req.)

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