Is the FDA writing a recipe for the failure of biosimilars in the U.S.?

Will FDA officials raise the regulatory bar on biosimilars so high they can't be competitive in the U.S.? Longtime researcher and trial consultant Dr. Saurabh Aggarwal seems to think there's a very high risk of that.

In an interview with Scientific American blogger Khadijah Britton, Aggarwal says that the FDA's latest stab at outlining the approval process for biosimilars highlights just how complex and expensive this will be. Add in an even tougher approval process that will be needed to achieve interchangeability-the right for pharmacists to substitute a branded biologic with a biosimilar--along with increasing signs that payers and providers won't settle for anything less, he adds, and you have a recipe for failure.

"The way the current biosimilars provision is written, if you want interchangeability to be on the label, you need clinical studies to show that you can replace the branded product," says Aggarwal, a regular contributor to Nature Biotechnology. "Step into the shoes of any of the current companies considering biosimilar development. You can use the analogy that biosimilar developers are like generic manufacturers, so their estimate of what they can invest is maybe 5-10 million dollars. The FDA approval pathway as explained so far would require far more than that."

Actually, of course, the FDA has made it abundantly clear for some time now that biosimilars will be on a completely different--and far more expensive--regulatory pathway than traditional generics. But if it's not feasible to get an interchangeable designation, then developers will likely get smacked with heavy resistance once they hit the marketplace.

"Take a scenario where no one gets interchangeability," says Aggarwal. "Then the pathway has biosimilars that aren't interchangeable. If the FDA says they're not interchangeable, then doctors don't want to use it and payers don't want to pay because they're worried that if something were to happen they couldn't support the use of those products...The fact is, you need interchangeability in the label to succeed. The amount of investment you need to obtain that designation--there is no financial model that would make the case to conduct those studies."

- here's the blog from Scientific American