Brian Biehn and Corey Ford from Cencora suggest improvements to current regulatory frameworks to better promote biosimilars for US patients and ensure market sustainability.
Brian Biehn, senior director of biosimilar commercialization, and Corey Ford, vice president of reimbursement and policy insights at Cencora (formerly AmerisourceBergen) describe different avenues for regulatory agencies to improve biosimilar promotion and create a sustainable biosimilar industry.
Visitors can listen to the full version of this interview in the next episode of Not So Different: a podcast from The Center for Biosimilars on December 31, 2023.
In what ways do regulatory frameworks need to adapt to accommodate the growth of biosimilars, and what impact might this have on the competitive landscape of the biopharmaceutical industry?
Biehn: We support any kind of regulatory change that's going to promote biosimilars. Right now, there's a push from our manufacturer partners to find any way that they can reduce their development costs. These are not like pure generics; [biosimilars] are much more costly to make. We're talking hundreds of millions of dollars to develop these. So the thing that we hear from our manufacturer partners all the time is how can we reduce those costs [and] how can we become more efficient and develop more biosimilars, which I think everyone in the industry is pushing for.
We promote anything that the legislators are looking to do or regulatory changes are looking to do to promote biosimilars and reduce those costs. I would say on the flip side of that, we do need to be careful of any changes where we potentially reduce the need for [for example,] starting clinical studies [as that can] impact the view of patients and providers in biosimilars. So, we still need to keep that confidence in these products—that they are the same as their brand counterparts. We need to look at that balance and make sure we still have that balance when we make these changes. But we are in favor of any changes that can be done to help our manufacturing partners reduce those development costs.
Ford: Now, I'll kind of tackle this from the CMS side, where we think about this from a Medicare perspective, specifically. By and large, I think from a Cencora standpoint, we're also very supportive of trying to enhance patient access within these government programs to biosimilars, and I think that also mirrors, frankly, how we have partnered with our manufacturer partners on this as well.
One thing to continue thinking about as we get more and more—which we're in the process right now with trying to have the regulatory guidance for the party redesign—is still trying to maintain some of those very important beneficiary protections. As I mentioned, with higher liability for plans, CMS is trying to strike the proper balance between offering plans [with] that flexibility to manage the Part D benefit, while still also building in strong beneficiary protections.
It's going to be very important knowing what plans are having to incur now that a lot of these beneficiary protections are still put in place, like the formulary review process that CMS says is still very rigorous to make sure that patients have a wide range of access to not just drugs and drug classes specifically, but also the types of products—both reference products and biosimilars.