Biosimilar Timelines
Dr. Levine says that the significant development of biosimilars in the U.S. depends on how quickly it takes for the FDA draft guidelines to become finalized and approved. “The FDA, by their own releases, has said they’ve already had discussions with, I believe, nine companies regarding biosimilar applications. They have several other meetings pending. So there’s obviously been a lot of activity behind the scenes, if you will, of companies approaching FDA even before the guidelines were published.”
Levine thinks that the first wave of biosimilars in the U.S. will most likely be those products that are already on the market as biosimilars in Europe. He points out that the clinical trial requirements for biosimilar under the new guidelines allow for a non-US reference product—meaning that companies should be able to submit their clinical and postmarket data against that European reference standard and it should be acceptable in a submission to FDA.
“What that means is really compiling the data and putting together the appropriate application and submitting the application without actually having to run any clinical trials,” he says. “So those will probably be the first products I would expect to see approved, and probably within the first year after the guidance is finalized. And then, obviously, beyond that, we’ll begin to see new biosimilar products that are not yet on the market in Europe.”
When asked what he thought would come next, Dr. Levine responded, “It’ll also be interesting to see what, if any, changes there are in the guidance between this current draft version and the final version. The document is open for public comment at the moment. I know that several of our clients, as well as other companies that I’ve spoken to at conferences and such, are planning to submit comments to FDA. So the question is really how long will it take them to compile all those comments and revise and update the draft before they release it as final?”