Christine Baeder Discusses the Future of the Biosimilar Industry, Insulins

The United States is going to have to wait and see whether adalimumab biosimilars will have sufficient uptake, and hopefully, they won't experience the adoption challenges observed in the diabetes space, according to Christine Baeder, the new chair of the Association for Accessible Medicines (AAM) and chief operating officer for US generics and biosimilars at Teva Pharmaceuticals USA.

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With the reauthorizations of the Biosimilar User Fee Act (BsUFA) and Generic Drug User Fee Act (GDUFA), the Inflation Reduction Act, and the US market introduction of adalimumab biosimilars, how do you see the generic and biosimilar industries developing over the next few years?

There's a lot of exciting possibilities. That's the good news. The bad news is if we don't take some action, and work together between regulators, legislators, and manufacturers, I don't know that patients are going to feel the benefit of that. So, GDUFA specifically, we made a lot of movement towards lifetime communication, and faster approval cycle. We could go farther, but we're happy that we made the progress we made.

The ideal state would be that the FDA very much partners in live time with manufacturers to get those drugs approved, especially first-to-market and complex generics. There tends to be sort of fits and starts; you submit a package of data, the FDA takes a few months to review it, you then get a letter back, you take a few months to review it, that goes back. Imagine a system where we can line everything up, and things move faster, and then we get to approvals faster. That’s, I think, everyone's ideal state, we're working towards getting there.

So, we made some progress on GDUFA, that's exciting. Adalimumab? We'll see what happens, right? I read the news, just like you do, and there's a lot of concern that we won't have the biosimilar uptake as quickly as we would like to have it. I also see that as an opportunity. So, if that does happen, what are we going to do from a policy and regulatory perspective to make sure we do better going forward? And how do we correct it? And how do we talk about incentives in a different way? So, it's all so exciting and full of possibility, it's just not clear to me what the answer is yet.

Eli Lilly just announced that it will significantly reduce the prices of their insulin products—including its recently launched insulin glargine biosimilar—and capping patient out-of-pocket costs to $35, in line with the Medicare Part D provision set out in the Inflation Reduction Act. What was your reaction to this news and do you think this could have an impact on insulin prices as a whole and the utilization of insulin biosimilars?

Insulin has been a challenging market for patients to feel any reduction in cost for a long time. So, I think everyone welcomes a different approach, and I certainly applaud Lilly for the for the actions that they've taken. I think it does beg a question; if you look at the insulin market and you look at Semglee [insulin glargine biosimilar] on how the incentives are structured and what's going on that you're not seeing the uptake of the biosimilars the way we would want to.

I'm very much watching Amgen, which just launched the first biosimilar to Humira [Amjevita], and if you notice, they also had a high-whack and a low-whack strategy, much like we saw with Semglee in the insulin space. So, if that continues to happen, you have to wonder why that's happening; why the lower-priced item isn't moving and we're not getting the uptake. I think that is raising a lot of questions and driving a lot of conversation, and we're talking about it in a way that we haven't talked about it. So, it's exciting to me that maybe that's the start of some new set of incentives or a new structure that helps us get those savings all the way through to the patient.