In a nutshell the firms are on track to file for FDA approval of a once-a-week version of their diabetes drug Byetta by the end of the first half of next year. Investor concerns that the timeline would be pushed out have pressured all three stocks recently. Many analysts believe the drug has mega-blockbuster potential.
Also, Eli Lilly has signaled aspirations to get into generic biotech medicines "down the road."
Biotechnology medicines, based on living organisms such as proteins and antibodies, are far more complex and expensive to manufacture and tougher to duplicate than traditional chemical pills. As a result, generic versions will likely not be considered direct substitutes for brand name drugs and are often referred to as biosimilars or follow-on biologics.
Congress has yet to approve a regulatory pathway for generic biologic medicines, but many industry observers believe such a law could be passed as soon as next year, following Europe's lead, as pressure mounts to cut healthcare costs.
Merck said this week it expects to have at least five follow-on biologics in late-stage development by 2012.
Lilly was not quite ready to make such a specific pronouncement, but its biotechnology prowess should grow dramatically with the integration of ImClone.
And on a related note, are you wondering who might be the next head of the FDA? Find out what Mike Huckman is hearing. Watch the video now!
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