Julie Reed: Biosimilar Policies Legislators Should Be Prioritizing

The Biden administration must follow through on its promises, and Congressional leaders must do more to push through bipartisan biosimilar policies to encourage better adoption and lower drug costs, according to Julie M. Reed, the executive director of the Biosimilars Forum.

Transcript

What sort of policy initiatives should legislators and the FDA be putting a greater focus on?

Reed: This is really the critical year, and we need the administration to follow up on the President Biden's executive order to do more with biosimilars; it's almost a 1-year anniversary. So, we need CMS to get some biosimilar programs out there. We've been talking for a long time and they're leaving cost savings on the table. [It's] really important, especially now.

So, that's one piece of it; the administration needs to act and follow up. In Congress, biosimilars have been a bipartisan solution for a number of yours. But unfortunately, politics have stopped some of our ideas and that are supported, as I mentioned, by both sides in the House and in the Senate. [Reimbursing at] ASP [average sales price] plus 8%, shared savings, and $0 copay. Those things need to happen, especially with the [adalimumab biosimilar] launches next year and [the biosimilars] launching in ophthalmology. We've launched a interchangeable insulin biosimilar. All these products are coming to fruition, yet patients don't have access to them.

And so, we need the administration and Congress to do something. The other piece, about the FDA, we, as stakeholders and partners with the FDA, have to get the BsUFA [Biosimilar User Fee Amendment], the super 3 pac that's critical, and then we have to partner with the FDA to to evolve the program through the science regulatory science program. So, that's really key. And then continue, like I said, our partnerships with the other agencies, like the FTC, the FDA, and CMS, to do everything we can to make us more successful.