The House Ways and Means Committee’s subcommittee on health tomorrow afernoon will hold the latest hearing on biosimilars, otherwise known as generic biologics. The controversial issue is pitting biotech and big pharma against a coalition of insurers, generic drug makers, patient and consumer advocates, and big employers.

Earier today, Pharmalot spoke with Jay Inslee, a Democrat from Washington state and a House and Ways committee member, who is co-sponsoring a biologics bill. His legislation, he says, serves as an alternative to a bill introduced by a group of 11 senators and congressional representatives, led by Henry Waxman.

Pharmalot: What are the essential differences between your bill and the Waxman bill?
Inslee: We would provide a 14-year exclusivity period, which is sort of modeled after the original generics legislation, the Hatch-Waxman act, because it maintains incentives. And we have clinical trial requirements for non-identical products. Given what happened with Vioxx, I think it’s appropriate for patient safety and also gives the FDA some flexibility.

Pharmalot: What are you trying to accomplish with this approach?
Inslee: In my district, we have an emerging biotech sector and I believe that we do need an FDA pathway. And I think they deserve to reap the fruits of their innovation. But of course, we don’t have (a pathway) right now. And at the same time, I believe patients need access to medicines and as reasonably priced as can be obtained, and on as timely a basis as possible. But we need a pathway that’s sound, that’s based on biological science.

Pharmalot: Sounds like you’re trying very hard to do a balancing act.
Inslee: Well, yes. It’s like a lot of things in life. We have a vibrant biotech industry in the Puget Sound area. And call consumers have an interest in having a biotech industry that’s healthy enough to yield innovation. And industry has an interest in generating access to their products in a way that doesn’t cause consumers to break the bank. We’re trying to hit that sweet spot. But you know, it’s unlikely to be a black-and-white debate. I don’t think there’ll be any one approach.

The witness list for tomorrow’s hearing;
The bill co-sponsored by Inslee;
Inslee’s web site;
The Waxman bill.[tags]Biologics, Biotech, Generics, Henry Waxman, Jay Inslee[/tags]