Health of the Biosimilars Industry, Getting Rid of Clinical Trials, PBMs As Obstacles and Other Biosimilar Topics | Q&A With Craig Burton, MBA

Craig Burton, MBA, executive director of the Biosimilars Council, gives the industry an incomplete.

As part of Managed Healthcare Executive’s coverage of biosimilars and managed care in 2025, we will be reaching out to leaders in industry and managed care, and outside experts and analysts who can provide insight and understanding into biosimilars and their market dynamics. Managing Editor Peter Wehrwein spoke recently with Craig Burton, MBA, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances for the Association for Accessible Medicines. The Biosimilars Council is part of the association, a trade association of generic and biosimilar distributors and manufacturers.

First of two parts. This transcript has been edited for clarity and length

What sort of letter grade would you give the biosimilar market? Is it working?Is it lowering prices? Is it a healthy market?

Those are all different questions. I'd give it an incomplete. I is delivering on the promise of lower prices. It is delivering on the promise of expanded access. It is not, today, a healthy market. It is not a market that is sustainable in the long run.

In order to realize the full potential of biosimilar competition, there are further policy changes that need to be made in order to make that reality.

And what are the unhealthy aspects and the policy changes that you're talking about?

If you look at the report that we commissioned through the IQ Institute that was released on Monday [Feb. 3, 2025] it showed that almost 90% of the brand biologics that will lose patent protection over the next 10 years do not have a biosimilar in clinical development. That should be deeply concerning to anyone interested in biosimilars.

The report highlighted a number of reasons for that. Some of these products are for orphan conditions and maybe are not as attractive. But a good number of them are not orphan conditions. They have sales of over a half billion dollars a year — many over a billion dollars a year — and they still don't have development.

The reason for that is because the adoption curve has been too slow and unpredictable.

The pricing trends in the infused market are not positive. The cost of development remains high — anywhere from $100 million to $300 million.

And on top of all of that, you have the uncertainty from the IRA [Inflation Reduction Act] price controls.

The combination of all of that appears to be putting a damper on investment in new biosimilar competition.

Are you looking for a future with no clinical trials required for approval of a biosimilar as a way of streamlining development and lowering costs?

FDA has already has done a lot of work in this space. [We are] complimentary and appreciative of the work that FDA has done on this. We simply think there's more you can do. I would say that it is our view that in the long run, phase 3 clinical studies should be the exception, not the rule.

Certainly, FDA can retain, the authority to say, “Hey, we need a clinical study.” But we think in most cases, that's not necessary, that the resources are there to give you more reliable results than you'd get through a clinical study.

Another thing you could do is adopt a global comparator approach, where the work that you're doing to bring the biosimilar application [to completion] in Europe also supports the work that you're doing to bring it in the U.S.

As far as adoption of biosimilars is concerned, from my understanding, the obstacle used to be seen as providers and whether biosimilars were really similar to the brand-name reference product. It is my sense that that is not the bottleneck anymore, and that the bottleneck now is coverage, which is to say PBMs [pharmacy benefit managers] and formularies. Do you accept the general picture I am painting — that the adoption issue has shifted.

I would generally agree with you. I think that the issues you saw early in the days of biosimilar adoption on the provider side are largely settled now. The reasons for that are that we've seen that as a molecule has been on the market, and providers have experience with it, they get much more comfortable with it, which makes sense.

Obviously, the dynamics for the medical benefit infused products are going to be different from those for the pharmacy benefit products. For the medical benefit products, increasingly we see an acceptance and comfort and support on the part of providers, and it typically comes down to which what product is most financially advantageous to the provider in a buy-and-bill setting.

For the pharmacy benefit products, it is all about the PBM.

At one point in the insulin biosimilar space we saw the PBMs preferring the [brand-name reference product]. We saw them rejecting claims for the biosimilar and pushing those claims over to the brand product. That did not translate to higher costs for the patient, because the PBM was making the patient whole. So, sure, maybe that's still accomplishing part of the goal [of biosimilars] of lowering cost for patients. But in the long run, that's shortsighted, because biosimilars have to be more than just a stalking horse that allows you to get a bigger rebate from the reference product.

What we've seen in the Humira [adalimumab] market is that big three PBMs* were not touching the biosimilars — until they did. CVS has released their data. They converted about 80% of share overnight [to biosimilars].

That’s great, but that that doesn't mean the PBM issues have been solved. I would point out that more Humira patients have been moved to the next-generation brand products, Skyrizi [risankizumab] and Rinvoq [upadacitinib] in the time that the Humira biosimilars have been on the market than have been converted to the biosimilars.

*CVS Caremark, Optum Rx and Express Scripts are the three largest PBMs.