The Top 3 Policy Initiatives That Could Impact the US Biosimilar Market

Julie Reed, MS, executive director of the Biosimilars Forum, weighed in on some of the biggest policy changes that could impact biosimilars, including the implementation of the reauthorization of the Biosimilars User Fee Amendment (BsUFA III) and the investigation into pharmacy benefit manager (PBM) practices.

Transcript

What are some of the big biosimilar policy changes that the industry should be keeping an eye on and what actions can providers and administrators take to push them forward?

Absolutely. There's a couple key ones right now—and I sound like broken record so I apologize—but right now, the Senate Finance Committee and Congress are looking at PBM transparency. And I think that's a good start, but it doesn't go far enough, especially for biosimilars. We know what the problems are. We know that they're not providing competitive access to biosimilars. They're not preferring biosimilars. They're not supporting their uptake and lower cost. They're asking for high rebates, which the opposite of what we're trying to do. We don't want to add cost, we don't want to add rebates to a biosimilar. We want to give the lower list price and lower patients out-of-pocket [costs].

I think another key piece is—and we're excited about—is under the BsUFA III user fee negotiations. We will be working with the FDA to streamline development of biosimilars, which is a critically important. We're partnering with the FDA and bringing our collective experience with getting approvals across the world for biosimilars and the decades we've been doing this. There's ways we can create efficiency within biosimilar development. And I think that'll be key. If you can approve a biosimilar in less than 10 years, which we should be able to do, and if we can reduce the costs, that will have an impact on the outcome for patients' costs and what we can do for them, and so I think that's right.

We will continue to work closely with CMS. The biosimilar special rule was part of the Inflation Reduction Act, and that is part of the the drug negotiation package that they're implementing. We continue to to work with CMS and that team so that will this special rule is implemented in an effective and positive manner for the long-term sustainability of the biosimilars industry. So, I think those are the 3 key things and, of course, will always be weighing in on patent reform and reducing barriers to bringing biosimilars to the US marketplace.