As an industry expert, you’ve likely heard the big news that multiple biosimilars for AbbVie’s blockbuster anti-inflammatory drug, Humira, are coming to market. While biosimilar manufacturers are excited to get their competitor products into market, should you be celebrating, too?
Could biosimilars hold the key to curbing rising Rx costs? From historical data to barriers for cost savings, here’s what you—and your clients—need to know.
Biosimilars: A Quick History
An Abbreviated FDA Pathway: The 2010 Biologics Price Competition and Innovation Act (BPCI Act) enabled an abbreviated FDA-approval pathway for biosimilars
Early Biosimilars: Sandoz’s Zarxio, a biosimilar to Neupogen, and Pfizer’s Inflectra, a biosimilar to Remicade, gained FDA-approval in 2015 and 2016, respectively
Biosimilars Gain Momentum: Since 2015, over 40 biosimilars have been approved by the FDA
Steep Competition for AbbVie’s Humira: In 2023, 12 biosimilar products will enter the market and compete with Humira
Why Biosimilars are Trending Now
Through sizable rebates and contracts that limit competition, AbbVie’s Humira—the all-time top-selling drug in the world—has maintained the majority of market share and a preferred status on nearly every pharmacy formulary for nearly 20 years. Because AbbVie’s market exclusivity has finally come to an end, payers are hopeful that biosimilar competitors will play a key role in impacting drug costs.
While biosimilars are intended to make biologic drugs more affordable and accessible to patients, the reality is more complex.
Humira Biosimilars: Approvals and Anticipated Launch Dates
| Name | FDA Approval | Concentration | Citrate Free | Interchangeable | Anticipated Launch Date |
| Amjevita | Yes | Low | Yes | No | January 31, 2023 |
| Amjevita HC | Ongoing studies | High | Yes | Seeking | Late 2023/early 2024 |
| Cylteza | Yes | Low | Yes | Yes | July 2023 |
| Hyrimoz | Yes | Low | No | No | July 2023 |
| Hyrimoz HCF | Pending | High | Yes | Unknown | July 2023 |
| Hadlima | Yes | Low | No | Seeking | July 2023 |
| Hadlima HC | Yes | High | Yes | Seeking | July 2023 |
| Hulio | Yes | Low | Yes | No | July 2023 |
| Abrilada | Yes | Low | Yes | Seeking | July 2023 |
| Yusimry | Yes | Low | Yes | No | July 2023 |
| Yusimry HC | Ongoing Trials | High | Unknown | Unknown | Unknown |
| Yumlyma | Pending | High | Yes | Seeking | July 2023 |
| Idaacio | Yes | Low | Yes | Seeking | July 2023 |
| AVT02 | Pending | High | Yes | Seeking | July 2023 |
What Will Dictate Market Share?
High concentration and Citrate-Free Formulations
In general, high concentration products require less volume which results in less pain at the injection site, and fewer injection site reactions. Less injection site pain appears to be true for citrate-free formulations as well. True market penetration of any single biosimilar will likely only occur with a high concentration, citrate-free product. AlignRx’s book of business reflects this, with 90% of Humira claims being for the high concentration NDCs.
Interchangeability
Interchangeability might be important from the perspective of a payer—who will want to have the least number of barriers to switch from Humira to a lower-cost biosimilar. Interchangeable biosimilars have met additional requirements and depending on individual state laws, may be substituted for the originator product without approval of the prescriber. Aside from Boehringer Ingelheim’s Cyltezo—a low-concentration product, most Humira biosimilars do not currently have interchangeable designation.
The Cost-Rebate Power Play
Because the “Big 3” PBMs: CVS Caremark, Express Scripts and OptumRx control an estimated 85% of all prescriptions in the United States, rebates will largely continue to dictate preferred formulary placement.
Economics dictated by AbbVie
If AbbVie decides to increase its rebate, it will be nearly impossible for biosimilars to gain market share—at least initially—to make the cost impact that many are hopeful for.
2023 Planned PBM Strategies for Humira Biosimilars
| PBM | 2022 Humira Formulary Status | 2023 Humira Formulary Status | 2023 Planned Humira Biosimilar Formulary Status |
| CVS | Preferred | Preferred | TBD. CVS wants to drive the lowest net cost in the category and has yet to announce their planned formulary status for Humira Biosimilars |
| ESI | Preferred | Preferred | Plan to cover some Humira biosimilars |
| Magellan | Preferred | Preferred | TBD. Magellan follows a low net cost formulary management approach so the Humira biosimilars will be reviewed for formulary status based on this approach. |
| Navitus | Preferred | Preferred | TBD. Navitus follows a low net cost formulary management approach so the Humira biosimilars will be reviewed for formulary status based on this approach. |
| Optum | Preferred | Preferred | Plan to cover up to three Humira biosimilars in the same formulary position as Humira. |
| ProAct | Preferred | Preferred | Plan to cover some Humira biosimilars |
What Does All This Mean for Your Clients?
We believe the initial impact to your client’s cost will be limited based upon the introduction of these biosimilars. Here are a few reasons why:
1. We believe most PBMs will include both biosimilars and Humira on their formularies. PBMs are not going to want to give up the rebate dollars with the aggressive guarantees they have put into the market recently.
2. It’s unlikely that the price differential between the biosimilars and Humira will be substantial enough to drive a utilization shift. Due to AbbVie’s ability to offer additional rebates, we believe costs will be similar.
3. Historically, employers have not been willing to give up higher rebate guarantees in exchange for a more clinically managed formulary. This can be seen with the low adoption of some of the more managed formularies of the Big 3.
4. Humira is a maintenance medication. It has been challenging to move market share to products in classes of medication where members are on them for extended periods of time. Once a member has been stabilized on a medication, they typically remain on their original therapy.
Reach Out Today With Any Questions
We can also assist in quantifying the potential impact for your clients and potential alternative solutions. Please feel free to reach out to your account team regarding this specific issue
