As the biosimilar market takes shape, companies are gunning to produce copies of some of the world's top-selling drugs. And according to a new Moody's report, with their star products wearing targets on their backs, AbbVie ($ABBV), Amgen ($AMGN) and Roche ($RHHBY) are most exposed to the new competition.
The report, "Biosimilars: Parsing the Industry's Pipelines," names AbbVie's Humira, Roche's Rituxan (a.k.a. MabThera outside the U.S.) and Amgen's Neulasta as among the most sought-after prototypes for biosimilar copies, with at least one company currently working on each in a quickly expanding field.
No surprise there: Humira, the best-selling drug in the world, generated close to $10.7 billion in 2013 revenue. After pulling in $7.1 billion in 2012, Rituxan had already netted $5.9 billion through the first 9 months of 2013. And Neulasta, in combination with Neupogen--the molecule on which it's based, which already faces biosimilar competition in Europe--churned out $5.8 billion in worldwide sales.
But while the races may be heating up in Europe and Asia, biotechs have some breathing room in the U.S., where biosimilars are at least three years away, Moody's says. "We expect development of biosimilar drugs to continue at a rapid pace, but while in Europe more than a dozen products are now commercialized, in the U.S. no company has yet filed for approval of a biosimilar drug since the existence of the FDA's new pathway for biosimilars," Moody's SVP Michael Levesque said in a statement.
And biosimilar development isn't exactly a cake walk, either. High expenses--and high risks of failure--have sent would-be contenders packing or scared them off in the first place. Roche, for one, has already seen a couple of late-stage Rituxan competitors bite the dust in Phase III trials, with Celltrion halting a late-stage trial last April and Teva calling it quits with its own version in October of 2012.
- see the release from Moody's
- read the report (sub. req.)
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