Gillian Woollett, MA, DPhil, senior vice president of Avalere, discusses policy and biosimilars in the United States.
Are there policy changes that would make the United States a better market for biosimilars?
Definitely we need policy changes, but how quickly we can implement what needs legislation, what needs regulations…all of those are delays, so I think what it comes down to is people understanding better what biosimilars offer; that as an economic matter they are essentially generics, and realizing because they’re approved by the FDA they are of the same quality and will have the same clinical outcomes as their reference. There are questions being raised that make it very, very difficult for biosimilars to penetrate. Plus, it takes a significant investment—about $500 million, a hundred times a generic—to get them to market. So, there needs to be a return on investment and yet, they’re being treated like brands, expected to be cheaper but costing more to produce. And so it’s a serious uphill battle.