5 Things to Know

The long-awaited launch of the first biosimilar for Humira occurred in January, followed by the launch of an additional seven biosimilars earlier this month, giving hope that employers will start realizing cost savings.  

When analyzing the specialty drug market, there are a few terms that are helpful to understand:

  • Biologic drugs are large molecules made by living cells; it is not possible to make an exact copy. Humira is a biologic drug.
  • Biosimilar drugs can have minor differences in structure compared to the original drug, the reference product, provided they do not impact clinical performance or safety.
  • While states have different substitution laws, typically only biosimilars that have an interchangeable designation from the FDA can be substituted by a pharmacist for the reference product. 

Springbuk data shows that Humira has been responsible for a whopping 12% of specialty drug spending for the last three years among commercially insured populations, largely due to its use in treating plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and inflammatory bowel disease. Below are five important points related to Humira and its biosimilars that will help you understand what to expect as we move forward.   

1. Not all Humira is the same

As Humira has evolved, it has become available in higher-concentration, citrate-free formulations with smaller gauge needles. Not too surprisingly, the market has shifted to these newer formulations because they cause less pain when injected. In fact, in recent Springbuk data, over 85% of spend on Humira is for higher-concentration, citrate-free formulations

2. The first Humira biosimilar was launched at the end of January 2023, but the first high-concentration, citrate-free biosimilars only became available in July 2023

Amjevita, the first Humira biosimilar to reach the market, is only available in a lower-concentration form. Seven more Humira biosimilars have launched as of July 16, 2023, including Hadlima, Hyrimoz, and Yuflyma, the first biosimilars available in the more widely used high-concentration, citrate-free form.

The introduction of multiple high-concentration, citrate-free products is likely to cause market pressure, resulting in decreased prices for both biosimilars and Humira.

The table below provides characteristics of Humira biosimilars that are currently marketed in the United States.  

3. So far, only Cyltezo has been designated as interchangeable with Humira, but other biosimilar manufacturers have or are expected to apply to the FDA for this designation

In most states, pharmacists can substitute a biosimilar for the reference product (original drug)when there is an interchangeable designation. Cyltezo is only available in a low-concentration form and cannot be substituted for prescriptions for high-concentration forms, likely limiting its impact on the market. 

4. Biosimilar discounts relative to Humira list price vary widely

Many of the biosimilar manufacturers have list prices just slightly below that of Humira, while others have large discounts, and yet others have both.

Biosimilars that currently have list prices that are about 5% less than Humira include:

  • Cytelzo
  • Yuflyma
  • Idacio

Biosimilars that have list prices that are about 85% less than Humira include:

  • Yusimry
  • Hadlima

And, perhaps most interesting, are biosimilars available at two price points relative to Humira:

  • Amjevita (5% and 55% discount)
  • Hulio and an unbranded version, adalimumab-fkjp (5% and 86% discount)
  • Hyrimoz and an unbranded version, adalimumab-adaz (5% and 81% discount) 

You are not alone if you’re wondering why a single drug would be sold at two very different price points. After all, you wouldn’t go to the store and see two identical refrigerators, one priced at $100 and one priced at $1,000, and decide to buy the more expensive one! In the pharmaceutical industry, rebates and volume-based discounts often drive continued use of the more expensive product

Some of the manufacturers are hedging their bets by offering both low-cost and high-cost versions of their biosimilars to appeal both to those looking for a large upfront discount, and those looking for the largest rebate.  

5. Biosimilar market share will be influenced by the formulary placement of biosimilars relative to Humira

Pharmacy benefit managers (PBMs) determine which drugs will be included on a formulary list and the tier level, which determines the level at which the drug will be covered. To date, two of the three largest PBMs have added biosimilars to their formularies at parity with Humira, allowing for flexibility in choice, but not necessarily creating an incentive to switch to a biosimilar.

Express Scripts (National Preferred formulary) and Optum Rx (standard formulary) have announced that they will include the following biosimilars, at parity with Humira:

  • Amjevita
  • Cytelzo
  • Hyrimoz
  • An unbranded version of Hyrimoz, adalimumab-adaz  

The other PBM in the top 3, CVS Caremark, has stated that they are still evaluating coverage of one or more Humira biosimilars.

What Should You Expect During The Remainder Of This Year And Beyond? 

With the launch of lower-cost Humira biosimilars at the more commonly prescribed high concentration, citrate-free formulation, we expect to see a substantial increase in use of Humira biosimilars in the second half of the year compared to what we saw in the first half.  

But, there are some mitigating factors.

Surveys of physicians have shown that many are more comfortable prescribing biosimilars to individuals who are new-to-treatment (have never taken the reference product), suggesting that we will see an increase in biosimilar use over time.

Your members who are already taking Humira, or just starting to take Humira, are also likely to impact the rate of adoption. It’s important to ask, and understand: When the biosimilars are placed in a formulary at parity with Humira, what is their incentive to take a biosimilar? There might be an incentive if cost share is significantly less than Humira, which could result from the use of the biosimilars with large discounts off Humira's list price. But, even that may not be an incentive because AbbVie, the manufacturer of Humira, offers copay assistance to many patients. This is why a fail-first approach, requiring members just starting treatment to use a Humira biosimilar first, is so important.

What Can Employers Do to Increase the Use of Biosimilars?

One step every employer can take now is to be sure members are educated about biosimilars to quell the idea that biosimilars are not as effective as the original product by providing information like this. More information on employer actions to increase biosimilar adoption from the National Alliance of Healthcare Purchaser Coalitions can be found here.

Meet the Author: Janet Young, M.D.
With more than 30 years of experience, Janet Young has provided clinical expertise to the development of healthcare analytics used in provider, payer, employer, and government sectors. Previously, Janet served as a Lead Clinical Scientist at IBM Watson Health, guiding clinical content development related to new models, methods, and analytics using claims, EMR, Health Risk Assessment, and socio-demographic data. 

Janet joined the Data Science and Methods team at Springbuk in Dec. 2019, and has been responsible for clinical oversight of methods and models. Janet received her M.D. from Yale University School of Medicine.