The Rise of Humira Biosimilars and the Battle for Market Share

One year ago, the most financially successful drug in history—AbbVie’s Humira—said goodbye to its 20-year throne of U.S. market exclusivity. This pivotal moment allowed Humira biosimilars to disrupt the market, promising increased competition and potential price reductions for this high-cost medication.

How has the landscape shifted one year into this new era?

In this article, I’ll provide needed details on Humira’s history, highlight the Humira biosimilar market since it lost U.S. market exclusivity, and discuss Humira biosimilar market trends.

The Block Buster Drug

AbbVie’s Humira—a monoclonal antibody (adalimumab) used to treat autoimmune disease—is the most financially successful drug ever to hit the market, bringing in $200 billion in revenue over its 20-year market rein. Since its 2003 debut, Humira's price has soared from $520 to nearly $3,000 per syringe, with annual insurer costs reaching $83,328 per patient for the 312,000 patients using it.

It was totally legal for AbbVie to increase Humira’s price without any competition.

AbbVie's strategy centered around a "patent fortress," extending Humira's patent life from 2016 to 2034 through over 130 patents in various categories like administration methods, formulations, manufacturing, and delivery devices. This legal barricade effectively blocked competitors, sidestepping antitrust issues legally, as confirmed by the Seventh Circuit Court of Appeals. Despite this, AbbVie agreed to allow biosimilars in the U.S. in 2023, with competitors paying royalties on sales, adhering to AbbVie's patent rights. You can read more details on the strategy here.

The Humira Biosimilar Market Since s/p Market Exclusivity

Nine Humira biosimilars have launched since Humira lost its market exclusivity last year.

Surprisingly (or not), many of these Humira biosimilars are not significantly cheaper than the brand name Humira, which has influenced how pharmacy benefit managers include them in their formularies. An interesting pricing strategy from Humira biosimilar manufacturers is having high-list and low-list-price versions of the biosimilars. Recall, the list price is the initial price the manufacturer sets before any discounts or insurance adjustments are applied. PBMs typically take home a percentage of the drug’s list price, so the higher the list price, the more they’ll make.

This dual pricing strategy mainly entices PBMs to cover the Humira biosimilar on their formularies. As you see below, five of the nine Humira biosimilars have a dual pricing strategy, with Hulio, Hadlima, and Yusimry offering the cheapest options.

Large PBMs like Express Scripts, OptumRx, and Caremark have all added the high-list price versions of Humira biosimilars to their formularies.

• In June 2023, OptumRx announced it would add Cyltezo and Hyrimoz to its formulary at parity with Humira. Cyltezo is an interchangeable biosimilar (pharmacists can replace Humira with Cyltezo without physician authorization) and has a list price of 5% to 6% below Humira’s. While Hyrimoz isn’t interchangeable, its list price is also 5% below Humira’s. So, still high list prices!

• In July 2023, Express Scripts announced it would include Cyltezo, Hyrimoz, and unbranded adalimumab-adaz on their National Preferred Formulary. However, the unbranded adalimumab-adaz will be listed at an 81% discount compared to Humira’s list price. Additionally, Mark Cuban’s Cost Plus Drugs partnered with drugmaker Coherus to make Humira biosimilar Yusimry, which is marketed at a price 85% below Humira.

• In January 2024, CVS Health (Caremark) announced it’d remove brand name Humira from some of its formularies in favor of Sandoz’s Humira biosimilar, Hyrimoz. Recall that CVS Health launched a subsidiary called Cordavis that will partner with drug manufacturers to commercialize and/or co-produce biosimilar products. Starting April 1, 2024, CVS will cover Hyrimoz on all its formularies and Hulio on some reimbursement lists.

The market response to Humira biosimilars has been lackadaisical at best. As of the turn of 2023, Humira biosimilars made up just 2% of the Adalimumab Volume Market Share.

Given the poor market penetration of Humira biosimilars, AbbVie’s net revenue for Humira in Q3 ‘23 totaled $3 billion, while Amjevita totaled $23 million.

Dash’s Dissection

When I wrote about this topic in January 2023, I brought up three questions to consider regarding Humira losing its U.S. market exclusivity. We now know the answers:

1. Will the list price of the new biosimilars be lower than Humira’s? Yes (but barely).

2. Will pharmacy benefit managers (PBMs) add the new biosimilars to their formularies? Yes, but really only those with high list prices.

3. Will the increased competition affect Humira’s market share? At this time, no.

The answers to the above questions aren’t static, though—they’re dynamic.

Market penetration by biosimilars typically takes years. For instance, Filgrastim biosimilars took over eight years to capture a 71% market share. After four years in the market, Insulin glargine still holds less than 10% market share. Similarly, Humira biosimilars might follow this gradual trajectory. In the EU, where Humira biosimilars have been available since 2019, it took four years to reduce Humira’s market share to 34%.

Humira biosimilars are essential for patients and the healthcare system since they can lower out-of-pocket costs. However, several challenges impede market penetration. Again, we have the wacky flow of money in the drug supply chain where PBMs (in charge of insurers’ formularies) favor high-priced drugs since they get a percentage of that price in rebates. In the EU, they’re not dealing with rebates, so Humira biosimilar market penetration occurred relatively quickly (they favor low-priced drugs).

Another hurdle is the limited availability of interchangeable biosimilars, which can be substituted for Humira without physician approval. Currently, Cyltezo is the only Humira biosimilar with this status, complicating market entry for others.

Finally, physician reluctance to prescribe new Humira biosimilars and patient hesitancy to switch from a long-used medication present significant barriers. For physicians, the effort of trying to figure out which Humira biosimilar is covered by a patient’s insurer is more work than simply prescribing brand name Humira. For patients, they might be wary of switching from a familiar treatment. To overcome these obstacles, biosimilar manufacturers and health insurers would need to improve awareness among both physicians and patients about the viable, cost-effective alternatives to high-priced Humira.

In summary, Humira biosimilars have entered the U.S. market with a dual pricing strategy, aiming to attract PBMs while offering some cost savings. Despite this, their market penetration remains minimal, hindered by factors like complex rebate systems favoring high-priced drugs, limited availability of interchangeable biosimilars, and physicians' and patients' reluctance toward transitioning from Humira. Influenced by these factors, the current market dynamics suggest that significant shifts in Humira's market share, similar to those observed in the EU, may take several years to materialize. This landscape highlights the need for increased awareness and education about biosimilar options among healthcare providers and patients to facilitate more informed treatment decisions and potentially reduce healthcare costs.