Biotech's Defense Against Generics: FDA

Memo to biotech investors: Chill out when it comes to worrying about the coming onslaught of cheaper, generic versions of top-selling biotech drugs.

Yes, I know that President Obama wants this to happen sooner rather than later. His health care reform plans call for the creation of a regulatory pathway in the U.S. that will allow for the approval and launch of so-called biogeneric drugs. And yes, cheaper biogenerics, if successful, pose a competitive threat to companies like Amgen(AMGN Quote), Biogen Idec(BIIB Quote), Genzyme(GENZ Quote) and Genentech(DNA Quote).

Last December, I wrote about the challenges facing biogenerics, but it's worth revisiting the topic again because of the spotlight focused on the issue by Obama's new budget proposals.

The reason I remain unconcerned for now is that Obama may set policy, but it's the folks who work at the Food and Drug Administration who will be in charge of writing the laws and regulations that will actually govern how biogenerics come to fruition in this country.

And if you take a look at the hard line the FDA has taken recently with biotech companies trying to manufacture their own biologic drugs, you'll realize that biogeneric makers face a rough road.

Earlier this week, Eli Lilly(LLY Quote) and Bristol-Myers Squibb(BMY Quote) said that the FDA is delaying add-on approvals for their cancer drug Erbitux because regulators want more data to ensure that Erbitux used in recent clinical trials to expand treatment into lung cancer and head-and-neck cancer patients is the same as the Erbitux used today to treat patients with colon cancer.