Humira Biosimilars Are Hitting the Market in 2023. Finally. But Will Prescriptions Follow?

A wave of biosimilars of the anti-inflammatory drug Humira (adalimumab) are expected to flood the market in 2023. There could be as many as 11on the market by the end of next year, based on current FDA approvals and pending applications.

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But doesn’t necessarily mean prescriptions will follow. Much will depend on rheumatologists’ willingness to use them. Surveys have shown that rheumatologists are increasingly accepting of biosimilars, but they still have concerns, not the least of which are efficacy and safety. Others include the economic impact on their practices: They want to be assured that using biosimilars won’t cause their practices to lose money.

And there are other factors, such as the deals struck between pharmacy benefit managers, payers and manufacturers that will determine which, if any, biosimilars get placed on formularies and whether they are given preferred status on those formularies.

Managed Healthcare Executive®spoke with Marcus Snow, M.D., recently about the advent of the Humira biosimilars. Snow is chair of the American College of Rheumatology’s Committee on Rheumatologic Care, a practicing rheumatologist, and an assistant professor at the University of Nebraska Medical Center College of Medicine.

Rheumatologists are already familiar with the use of biosimilars that have been available for Remicade (infliximab) and Rituxan (rituximab). Their experience with these agents will affect their willingness to switch or start patients on biosimilar versions of Humira.

“I have had patients switch, and for the most part it’s been a good experience,” Snow said. “I think that, with time, we will become comfortable with that, but the switching of a well-controlled patient to a different product is concerning.” Snow said he will feel more comfortable using Humira biosimilars with interchangeability designations, because these agents will undergo extra layers of clinical testing to verify that outcomes will be the same if patients switch back and forth between biosimilar versions of Humira and Humira itself.

Speaking for rheumatologists in general, Snow said “the interchangeability data are going to be very, very helpful, and I think they will increase use of biosimilars.” As of this writing, just one Humira biosimilar, Cyltezo, had attained interchangeable status, but there is potential for at least four others to receive this designation.

With so many biosimilars of Humira, payers may change their preferences over time, and this could interfere with consistent treatment of patients, Snow said. “Our patients’ medication may be switched from one to the other regularly, and that’s our biggest concern. Consistent interchangeability data would really help us out and ensure that switching is not going to be causing problems.”

Once biosimilars have been approved for one indication of the originator product, the FDA may allow physicians to use them for other approved indications of the originator product. Extending approval to other indications is called extrapolation. However, biosimilars may differ in small ways from originator products, and although extrapolation has become more widely accepted, more clinical data on biosimilars would ease concerns, Snow said. “Extrapolation has always made us as rheumatologists uncomfortable. When drugs get approved, there are not always the data that we originally wanted on disease states.”

Humira is approved for multiple indications, including ankylosing spondylitis, psoriatic arthritis, Crohn disease, ulcerative colitis, and rheumatoid arthritis, and individual biosimilars of Humira, such as Cyltezo and Amjevita, have been approved for many indications of the originator product. In a position paper on biosimilars, the American College of Rheumatology has called for post-marketing monitoring of individual biosimilars for differences, such as adverse events, and for use of biosimilars in children.

Despite lingering concerns about biosimilars, these products do offer the potential to make healthcare more affordable. The price of Humira has risen steadily for decades. By the beginning of 2021, it cost as much as $84,000 for a full-year’s supply of Humira in the United States. Insurers’ may pick up a large portion of that expense, but patients’ out-of-pocket costs can still be high. “Hopefully, with the increasing competition from growing availability of biosimilars, the cost of medication will start to come down,” he said.

Manufacturer pricing strategies will be a factor in how soon this occurs. In the European Union, biosimilars of Humira had taken a 59% share of the market by February 2021. Experience in the United States with biosimilars for other rheumatology biologic drugs suggests that biosimilar pricing has been very competitive. From the fourth quarter of 2019 to the second quarter of 2021, three biosimilars of Rituxan captured a 55% share of the Rituxan market. By the end of that period, one of those biosimilars, Truxima, was offered at a 36% discount to the originator’s price (before biosimilar competition).

The average sales price of the anti-inflammatory drug Remicadedropped 49% from the end of 2016 to the second quarter of 2021. Remicade biosimilars, however, achieved just a 26% share of the market from Remicade in that time. One difference that might explain the better uptake for Rituxan biosimilars is that Rituxan had dropped just 6% in price by the second quarter of 2021, whereas the makers of Remicade had discounted that product much more heavily

If biosimilars of Humira fail to lower costs, are these other drugs acceptable alternatives? Snow said that “adalimumab has a really important role in treating autoimmune disease, but so do all the other biologics and nonbiologic medications we use.”

He continued, “Adalimumab certainly has a well-established niche. I‘m really glad we have the opportunity to use all the biologics and all the nonbiologic medications to help our patients, because, if you look at rheumatoid arthritis control over the past forty years, there has been an amazing improvement,” Snow said.