Generic-drug makers' long wait may finally be over. Bloomberg quoted FDA Commissioner Margaret Hamburg as saying that the agency will have guidance for how to get biosimilars approved "very soon."
That's an untapped multibillion-dollar market, Fools.
Currently, generic-drug makers can get copycat versions of small-molecule drugs approved, but there's isn't a corresponding pathway to get biologics approved. Last year's health-care reform law provided a framework for the FDA to establish one, but the agency hasn't determined the rules yet.
I don't think the agency is dragging its feet; it's just a very complicated issue. Because they're produced in living cells, there are a lot more variables in manufacturing biologics compared to small-molecule drugs that are produced through chemical synthesis. There's a reason they call them biosimilars.
When the agency finally releases its guidance, the thing investors should look for is whether clinical trials will be required to prove that the biosimilars work the same as their branded counterparts. In addition to delaying biosimilars' entry into the market, clinical trials could be prohibitively expensive, making them not worth developing. Merck
My guess is that the agency will tailor the rules to the individual drugs. Well-characterized drugs will have more lenient rules than those where the variables are less-known. The FDA actually approved one generic biologic years ago, Novartis'
I guess we'll know "very soon."
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