Are Humira Savings Just Around the Corner?

5 Things to Know

The day is finally here! More than 20 years after it was first approved in the United States, Humira will have competition from Amjevita, the first of several copycat drugs known as biosimilars, that are entering the market this year.

With specialty drugs continuing to be a driver of employer healthcare costs, any untapped savings opportunities would be a welcome relief. 

With sales of over 17.3 billion dollars in the United States in 2021, even a small price break could result in large savings. 

More information on potential biosimilar savings opportunities can be found here.

This holds true in the commercial market, where Springbuk data shows that Humira has been responsible for 12% of specialty drug spending for the last three years, largely due to its use in treating plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and inflammatory bowel disease. 

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. 

As the launch date (January 2023) for the first of the Humira biosimilars nears, below are five important points related to Humira and its biosimilars that will help you understand what to expect in the coming year. 

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 will be launched at the end of January 2023, but the first high-concentration, citrate-free biosimilar won’t be launched until July 2023. 

Amjevita will be the first Humira biosimilar to reach the market, available in a lower-concentration form, with an expected launch date of Jan. 31, 2023. 

Seven more Humira biosimilars are set to launch in or after July 2023, including Hadlima, the first approved biosimilar available in a high-concentration, citrate-free form. Other Humira biosimilars are still working to gain approval for higher-concentration forms.

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

The table below provides characteristics of Humira biosimilars that have been approved to date. (Several other manufacturers of Humira biosimilars are in the process of seeking FDA approval.)

Humira Biosimilars Approved as of Nov. 10, 2022

3. Thus 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 market share will be influenced by formulary placement by payers.  

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. 

Placing one or more of the Humira biosimilars on the formulary and on a lower tier than the reference product is especially important in driving the use of the biosimilars to increase the number of original scripts written for this drug, particularly since there is only one interchangeable biosimilar. 

It may seem counterintuitive that a biosimilar drug with a lower price point would NOT be preferred over the higher-priced reference product, but rebates and volume-based discounts often drive continued use of the more expensive product. 

More information on employer actions to increase biosimilar adoption from the National Alliance of Healthcare Purchaser Coalitions can be found here.

5. Humira biosimilars will be competing with Humira, as well as with newer drugs that have been launched to compete in the same market. 

For example, AbbVie, the manufacturer of Humira, has launched two drugs that have many of the same indications as Humira, emphasizing characteristics that may result in a preference for the newer drugs, even at higher price points. 

Newer AbbVie drugs that will compete with Humira include:

• Skyrizi – a drug that can be administered less frequently than Humira. AbbVie also reports that patients with plaque psoriasis using this drug have clearer skin than with Humira.
• Rinvoq – an extended-release oral tablet, which may be preferred by members who don’t want to use an injectable medication.

What should you expect this year and beyond?  

While we don’t have a crystal ball, it seems likely we won’t see the full impact of Humira biosimilars until high-concentration, citrate-free biosimilars are launched later in 2023. Currently, only one such biosimilar has been approved, but others are seeking approval. Significant price drops are more likely to occur as more of these biosimilars enter the market. 

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. 

But potential savings from biosimilars require that they be on the formulary. Now is a good time to find out if and when your health plan partners will adopt Humira biosimilars.