Julie Reed Catalogues Actions Needed to Ensure Biosimilars Benefit Patients

Combatting misinformation surrounding interchangeability and incentivizing biosimilars are just some of the many things that can be done to ensure patients benefit from biosimilars savings, said Julie M. Reed, the executive director of the Biosimilars Forum.

Transcript

What needs to be done to ensure that patients benefit from biosimilar savings?

Reed: So, market barriers and access need to be improved. And as I mentioned, it's coverage on formularies, it's access through PBMs [pharmacy benefit managers] not just to 1 biosimilar but to multiple. That will get us robust competition, robust price decreases, and robust cost savings.

Changing policies that disincentivize and don't provide a level playing field.
So, having Medicare look at Medicare Part D, and consider ASP [average sales price] plus 8%, which is technical. But it means that the provider will have a level playing field against the reference product because they're not incentivized to use a lower-cost biosimilar given the current way the policy is written.

We've looked at and what we have experienced, because our members are global multinational companies, they've done biosimilars around the world, and we know that shared savings programs work. And we see those in the United Kingdom as well as other places in Europe.

So, we encourage CMS to consider a shared savings program both sharing the savings with the physician to use biosimilars, but also sharing savings with co-pay reductions for Medicare beneficiaries. The money that we save using a biosimilar should also go back to the patient and into their pocket, which is the whole meaning behind this. So, there's that piece, market access.

Second thing to continue to improve biosimilars, which we're very active right now, is to make sure we have a robust FDA. So, BsUFA [Biosimilar User Fee Amendment] 3 is critical. It funds the FDA and funds the development programs that are underway. We're excited about the [Biden administration's] commitment letter, and we were a key part of the negotiations. The way the BsUFA 3 is written is, I think one of the key components, is the regulatory science workshops that'll happen. That is perfect timing.

We have 10 years of experience with our member companies doing global development and in the United States and 10 years that the FDA's experienced developing and approving biosimilars. We can take all of that knowledge into the regulatory science workshops and work with the agency to scientifically evolve the approval program of a biosimilar. And what we're excited about and where we'll work very closely with the FDA is, what is the scientific components needed to approve a biosimilar today and in 15 years and 20 years vs 10 years ago. So, I think that'll be great.

Another big piece is this is a critical year, I was reading a paper this morning to remind myself, you know, IQVIA predicts we will have savings of $133 billion for biosimilars by 2025. That's 2 years basically from now considering the time warp we're all in, we're into 2023. But we have a long way to go and a lot of that savings is going to come from the competition of biosimilars for Humira [reference adalimumab] and that's why I think also it's such a critical year.

And one of the key pillars where we've been working on even more is education and combating misinformation. We're seeing misinformation about interchangeable vs non interchangeable biosimilars. That's critical with the 7 Humira [biosimilars] launching next year, all interchangeable or non-interchangeable, a biosimilar approved either way is a biosimilar and it's approved to have the same safety, quality, and efficacy as every other biosimilar.

It doesn't matter if you're interchangeable or not. That's key because that is something we don't want to hear or see is that a physician or a patient or stakeholder thinks that an interchangeable biosimilar is safer or higher quality or has better data with it. That's not true. And the FDA is going to help us with that through our education programs.

Interchangeability is only meaningful if the product is going to be dispensed by a pharmacist without a physician interaction. So, that's something we are anticipating, to have misinformation, and the agency is alerted. As we continue to educate they're going to work with us to educate on that. We're also going to continue one of the key things the Forum does is look for misinformation. And we work closely with the FDA and FTC [Federal Trade Commission] because it's our job as industry to make sure patients and physicians and stakeholders have competence. And so, we can't let up on not reporting these cases.