Ashley Gallagher is an associate editor for Pharmacy Times.

Ashley Gallagher

Julie Reed, executive director of the Biosimilars Forum, explains the thought process behind launching adalimumab biosimilars at 2 wholesale acquisition costs (WACs), whether this pricing strategy actually helps patients, and if the United States will see it permeate into other markets.

Several of the companies that launched adalimumab biosimilars in 2023 chose to use a dual-pricing strategy, where the biosimilar was priced at 5% and 55% lower than the originator Humira. Why did these companies chose to do this and do you expect a similar strategy to be used for future launches in other highly-competitive markets?

Unfortunately, yes. And we saw that with the Biocon Semglee [insulin glargine biosimilar] as well—they were forced to do that. Why they are being asked to do that is the product that only has the 5% discount, is a high WAC and highly rebated. So, they would—and I think most biosimilar manufacturers would—prefer to launch with the big discount. To get access to a formulary and access to the market, they're being required to put a high rebate on. And so the patient's out-of-pocket cost on a high rebate product are going to be based off of a 5% discount, not a 45% or 55% discount. That's not fair to the patients.

I think another piece, which is a concern—and we saw this before early in the biosimilars marketplace—we continue to see that the reference product, the brand is on the formulary at something called parity so everybody's equal. Well, biosimilars require incentives; there's a reluctance. [Patients think], "Well, if I think continue on my brand, why change?" And really, if it's a high rebated product, there's no incentive for the patient because they're out-of-pocket costs because of the rebate are not going to be lower. So I think that's key.

Also a concern is that we're seeing something called a step through on the PBM [pharmacy benefit manager] formularies, where a patient would have to step through the [reference product] before they could get the biosimilar. It's also called fail first. Well, I sat next to [Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars]—I think most know she's a board-certified adult rheumatologist—and from a physician standpoint, if you fail on the [reference product], the physician is not going to prescribe you the biosimilar. It's unethical. They are the same drug.

So why would any PBM put a step through on the reference to the biosimilar? It's medically unethical, so why? Because they want to limit the access to the biosimilar. This is something I think Congress needs to look into, the Federal Trade Commission needs to look into. [This is] not the right thing to do, and it's of grave concern.

Videos

Why are companies pricing their adalimumab biosimilars with 2 prices? Can the United States expect more of this pricing strategy for future biosimilar launches? Julie Reed, executive director of the Biosimilars Forum, has the answers.

Why Are Companies Launching Biosimilars With 2 Prices? Julie Reed Explains

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.

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.

Julie Reed, MS, executive director of the Biosimilars Forum, takes a look at the 3 policy initiatives that could have the greatest ramifications for the US biosimilars industry.

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

Unless pharmacy benefit managers (PBMs) stepping up to support biosimilars and provide broad access to these lower-cost products, the promised savings from ranibizumab and adalimumab biosimilars are going to develop slowly and a healthy competitive marketplace will be in jeopardy, said Juliana (Julie) Reed, executive director of the Biosimilars Forum, in an interview from Asembia 2023.

Although anticipated savings related to adalimumab and ranibizumab biosimilars are expected to develop over a long period of time, how long do you think the US will have to wait to see big price changes, and what needs to happen to ensure ample competition between products?

So I think that we could see immediate savings if the PBMs [pharmacy benefit managers] changed their model—they embrace biosimilars, they embrace competition, and they moved towards providing that and providing access. Otherwise, the savings will be slow. And it's not because [the Forum's] members did not develop or take all this time. If we have [9] biosimilars to Humira [adalimumab] is launching at 10 years of development, that's [90] years of development, and over $2 billion spent. And that's the concern—that all this time, these years, and all this money but PBMs won't provide access, and I mean preferred access. They need to support the industry. They need to support the competition. 

IQVIA and other economists have said that we could see close to $155 billion in savings by 2025. That's 2 years from now and that has a lot to do with those biosimilars launching. Those are real numbers and there's concern that those savings will not be realized. And I think the question will be why? Because we certainly we developed the biosimilars and we're bringing them to the marketplace, and we know they're safe and efficacious and approved by the FDA. So if we don't achieve those savings, the question is why, and we know that it's because we don't have access to the market and we're not able to compete.

Juliana (Julie) Reed, executive director of the Biosimilars Forum, predicts how long it will take for savings from adalimumab and ranibizumab biosimilar competition to fully manifest and how stakeholders can champion for better market competition for biosimilars.

Ashley Gallagher

Why Are Companies Launching Biosimilars With 2 Prices? Julie Reed Explains

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

Julie Reed: When the US Could See Meaningful Savings From Adalimumab, Ranibizumab Biosimilar Competition