8 Humira Biosimilars now Available, but Formulary Questions Remain

Over the July 4 holiday weekend, seven Humira (adalimumab) biosimilars were launched, with various formulations and pricing options. They join Amgen’s Amjevita, which was launched January.

Humira is blockbuster drug that generated 2022 sales of more than $18.6 billion in the United States. It is used to treat several immune conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, ulcerative colitis, Crohn’s disease, uveitis, and hidradenitis suppurative. It has a wholesale acquisition cost of $6,922 for a four-week supply.

Formulary placement and outcomes are expected to drive the use of the biosimilars. But it could take 12 to 18 months to get an understanding of the impact of the biosimilars, Bruce Feinberg, D.O., vice president and chief medical officer at Cardinal Health, told Formulary Watch earlier this year.

Related: Formulary Placement and Outcomes to Drive Physician Use of Humira Biosimilars

Jon Martin

For the remainder of this year, we can expect the biosimilars to be added to formularies along with Humira, Jon Martin, associate vice president of Organon, said in an interview. But going forward, the market will begin to change, with Humira beginning to be dropped from formularies in 2024.

Organon and its partner Samsung Bioepis launched Hadlima with a single list price that is an 85% discount off Humira. Hadlima is available in both citrate-free high concentration and citrate-containing low concentration. A carton including two pre-filled pens or two pre-filled syringes is available at a list price of $1,038. The company also is planning to submit an application for Hadlima to be interchangeable with Humira, and Martin expects this to be available in the third quarter of 2024.

Martin said the company is pricing Hadlima with access and affordability in mind. “Pricing is a driver for change for the physician,” he said. “At the end of the day, the prescription is still won and lost at the physician level.”

The lower price also increases access to patients with Medicare, as well as to those who are unaware of copay cards or those who have exhausted their copay benefits. “We believe the low list price strategy enables patients to receive some of this value while securing formulary status.”

As far as coverage, among the larger PBMs, only Optum Rx has weighed in so far. Optum Rx last month indicated that that it would offer access to Sandoz’s Hyrimoz (at a price 5% and at 81% below Humira); Boehringer Ingelheim’s Cyltezo (at a price 5% to 7% below Humira); and Amgen’s Amjevita (5% and 55% below the list price of Humira). They would be offered on parity with Humira. All four products on will be on Tier 2 of standard formularies with prior authorization required and quantity limits.

A spokesperson for CVS Health said they are reviewing the biosimilar products and plan to recommend coverage of one or more of these products.“When a biosimilar is new to market, we carefully assess its efficacy, product attributes, supply, and cost to our clients and their members," the spokesperson said.

Express Scripts will include Cyltezo and both Sandoz products (Hyrimoz and unbranded adalimumab-adaz) as preferred products on its National Preferred Formulary alongside Humira. The biosimilar Amjevita, a citrate-free, low concentration formulation, is currently preferred on the Express Scripts NPF and the National Preferred Flex Formulary for 2023.

A spokesperson for Prime Therapeutics indicated that the PBM will recommend formularies include Humira and a mix of its biosimilars so plans can choose the approach that is best for their members. "Prime remains committed to delivering the best drug management experience while empowering providers and members to make the best decisions for improved health and minimal disruption of therapy," the spokesperson said. Prime is owned by 19 Blues plans.

Among the smaller PBMs, SmithRx and RxPreferred have teamed with Mark Cuban Cost Plus Drug Company to provide Coherus BioSciences’ Yusimry through the online mail-order pharmacy for $569.27 plus dispensing and shipping fees. SmithRx members will also be able to apply their insurance benefits.

Here are the eight biosimilars and their pricing:

• Amjevita (adalimumab-atto), the first of the Humira biosimilars, launched in January and was offered at two price points: 5% and 55% below the list price of Humira. Developed by Amgen, it is available as a citrate-free prefilled syringe and as an autoinjector.
• Cyltezo (adalimumab-adbm), Boehringer Ingelheim’s biosimilar is priced at 5% to 7% below Humira. It is the first biosimilar with an interchangeable designation. It is available as a prefilled syringe and as pen autoinjector.
• Hadlima, (adalimumab-bwwd) has launched with a list price that is an 85% discount off the reference product Humira. Hadlima, developed by Organon and Samsung Bioepis, is available in both citrate-free high concentration and citrate-containing low concentration. A carton including two pre-filled pens or two pre-filled syringes is available at a list price of $1,038.
• Hulio (adalimumab-fkjp) injection, from Biocon Biologics, is being offered with two price options: 5% below the current Humira list price, and at a price that is 85% below Humira. Hulio is available as a prefilled pen.
• Hyrimoz (adalimumab-adaz), a citrate-free, high concentration formulation from Sandoz. Hyrimoz HCF is available at a list price, that is 5% below Humira list price. Sandoz is also offering an unbranded adalimumab-adaz HCF at 81% below Humira list price.
• Idacio (adalimumab-aacf) from Fresenius Kabi, is available in a self-administered pre-filled syringe and a self-administered pre-filled pen (autoinjector). It is a citrate-free formulation. The company did not provide pricing information, but a Reuters article indicated it would be offered at a 5% discount to Humira.
• Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira biosimilar developed by Celltrion, launched with a price of $6,576.50 per month. Yuflyma is available in two device types — auto-injector and pre-filled syringe options.
• Yusimry (adalimumab-aqvh) from Coherus BioSciences launched at a price of $995 per carton for two 40 mg/0.8 mL autoinjectors, representing a discount of more than 85% to Humira.

Missing from this is Pfizer’s Abrilada (adalimumab-afzb), which received U.S. approval in 2019 and is awaiting FDA approval for an interchangeable version. The company has not responded to a request for an update on when Abrilada will launch.

This story has been updated to include information from Express Scripts and Prime Therapeutics.