The Year of Humira Biosimilars is Finally Here
-Updated 2/1/23 with pricing information on Humira biosimilars-
2023 will be an unprecedented year in pharmaceutical history. This year, Humira, the blockbuster drug from AbbVie, will lose exclusivity. With Humira bringing in over $20 billion in sales annually, this is considered the largest loss of exclusivity event in pharmaceutical history.1
Humira is a biologic medication, which means it is a large, complex molecule derived from living cells. Due to the nature of these medications, it is impossible to precisely replicate the brand biologic drug like with generic drugs in the past. In the context of marketplace dynamics, biosimilars can be thought of as “generic” biologic medications because they are considered highly similar to the biologic with no clinically meaningful differences. Additionally, they compete directly with the originator or reference biologic. However, it is important to note that biosimilars are technically branded products that come with all the considerations of brand medications (copay structures, rebates, etc.). The first biosimilar in the U.S. was launched in 2015, and there are currently 40 biosimilars approved for various reference products. There are eight approved biosimilars for Humira expected to launch in 2023 with 14 or more total biosimilar launches expected through 2024.
The first Humira biosimilar, Amjevita, launched on January 31st, 2023. This product will be the sole Humira biosimilar on the market until others launch in July. Biosimilar use will depend on provider adoption, formulary placement, current Humira utilization and member disruption. Pharmacy benefit managers (PBMs) may choose to cover these biosimilars or they could be excluded in favor of Humira as AbbVie will likely utilize rebate dollars to compete against biosimilars for market share. See the end of this article for an update on pricing published on February 1, 2023.
Humira is available in two different formulations, referred to as high or low concentration. About 85% of Humira utilization consists of the high-concentration formulation and we expect this trend to continue as biosimilars launch. The availability of high-concentration biosimilar options will likely be preferred as it reduces disruption and the risk of medication errors for a majority of patients. Currently, the only approved high-concentration biosimilar, Hadlima, will launch in July while others are still in the pipeline.
Lastly, since biosimilars are not identical to the reference biologic, they require prescribers to select the exact biosimilar brand before switching from the reference product. Unless the biosimilar product is considered interchangeable by the FDA, the prescriber must be contacted before a pharmacist can make the switch. Currently, there are only four biosimilars with this designation, including Cyltezo, a Humira biosimilar that will be launching in July. As the first Humira biosimilar with this designation, Cyltezo will have exclusivity as the only low-concentration interchangeable biosimilar to Humira for about one year. However, the significance of marketplace uptake is unclear as prescribers will likely be contacted by the specialty pharmacist before switching to biosimilars regardless of interchangeable status.
Overall, biosimilar adoption and price erosion are not expected to occur rapidly in 2023, but rather over the next few years as the market becomes saturated with biosimilar options. Besides Humira, another popular biologic used to treat severe psoriasis, Stelara, will be losing exclusivity this year and biosimilars are expected to enter the market towards the end of 2023. Over the past six years, there has been an estimated $21 billion cumulative reduction in drug spend due to biosimilar competition. We expect this figure to rise as more biosimilars enter the market.2
-2/1/23 Pricing update-
Amjevita is being launched at two list prices (Wholesale Acquisition Cost), one at 5% less than Humira and one at 55% less. Amgen states that they offer these two pricing options to reflect the value of the medication while also providing flexible pricing to ensure patient access. We believe that the version available at a 5% discount will fit the PBM contracting structure in which rebate guarantees have already been finalized for the next few years. Because Humira is a highly rebated product, positioning Amjevita to offer competitive rebates will promote formulary placement, which is step one of gaining market share. Alternatively, the version available at a 55% discount to Humira may provide access for patients outside of the traditional PBM model. However, it will be made in a limited supply when compared to the 5% version. With seven other Humira biosimilars approved and set to launch this year, Employers Health will continue to monitor market dynamics and provide relevant updates to clients and consultants as the information becomes available.