New, Cheaper IBD Drugs Approved in US: What You Need to Know

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More than 3 million U.S. adults live with inflammatory bowel disease (IBD), a medical condition encompassing Crohn’s disease and ulcerative colitis. These sometimes painful conditions are characterized by persistent inflammation in the gastrointestinal tract (GI), leading to potential GI damage.

Humira (adalimumab) is one biologic drug that has proven effective in alleviating symptoms of IBD and other autoimmune disorders. However, its cost can be exorbitant, reaching thousands of dollars when paid out-of-pocket. Although most health insurance generally includes coverage for Humira, the extent of coverage can vary depending on the individual plan.

Cheaper but equally effective alternatives are finally available in the United States, which could bring significant savings to both patients and providers.

In 2021 alone, the United States spent $256 billion on biologic drugs, constituting more than half of the nation’s spending on prescription medicines, even though biologics account for only approximately 3 percent of all prescribed medications in the country.

Rationing Meds Risks Serious Health Issues

About one-third of U.S. adults reported not taking medicine as prescribed in the past year due to costs, according to a 2019 poll by the KFF, a nonprofit organization focused on national health research. About 12 percent cut pills or skipped doses, and 30 percent of those not taking medicines as directed said their condition worsened.

An estimated 125,000 deaths per year in the United States stem from medication nonadherence and up to 69 percent of medication-related hospital admissions results from poor adherence.

IBD patients who ration medications to save money may spur disease flares and reverse remission, Anthony Longo, who holds a doctorate in pharmacy and is a pharmacy director at Northwell Long Island Jewish Forest Hills in New York, told The Epoch Times.

New Biosimilars Offer Hope for Lowering Humira Costs

In 2019, Humira’s manufacturer AbbVie faced a congressional subpoena and questioning over pricing practices that may have inflated treatment costs. That year, AbbVie charged about $77,000 for a year’s Humira supply—470 percent more than its 2003 launch price.

Recently, the U.S. Food and Drug Administration (FDA) approved biosimilar versions of Humira that could significantly reduce costs. “A biosimilar is a biologic agent that has been approved by the FDA to be highly similar to and have no significant differences from an existing FDA-approved biologic agent in either their safety or effectiveness,” Mr. Longo said.

In 2017, drugmakers AbbVie and Amgen signed a patent settlement allowing the commercialization of Amjevita, a biosimilar form of Humira. This granted patent licenses for using and selling Amjevita in the United States starting in January 2023.

Amjevita’s manufacturer prices it 55 percent below Humira’s current list price. However, even with that discount, Amjevita still costs over twice Humira’s initial price when launched.

Besides Amjevita, seven more Humira biosimilars are coming to market this summer, with two discounted up to 85 percent below Humira’s $6,922 list price. These include the following:

• Cyltezo.
• Hadlima.
• Hulio (pdf).
• Hyrimoz (pdf).
• Idacio.
• Yuflyma.
• Yusimry.

In July, the Mark Cuban Cost Plus Drug Company started offering Yusimry to its customers for $569.27, plus dispensing and shipping fees, according to drugmaker Coherus. In 2003, when Humira was introduced, it was priced at $522 for a 40-milligram syringe (pdf), or about $856.43 when adjusted for inflation.

Health Risks of Biologics and Biosimilar Drugs

Biologics like Humira effectively treat IBD by inhibiting a protein called tumor necrosis factor (TNF) to reduce inflammation. However, these TNF inhibitors and their biosimilars come with the same possible side effects and risks.

A significant risk is suppressed immunity and increased susceptibility to infections. Other potential side effects include injection site reactions, skin infections, inflammatory skin conditions, and increased cancer risk, especially lymphoma, since, theoretically, TNF inhibitors may decrease our natural defense against malignancy.

Other side effects associated with Humira include stomach pain, nausea, headache, and muscle or bone pain. In rare cases, patients may experience severe reactions, including anaphylaxis.

Although intended to treat autoimmune disease, TNF inhibitors paradoxically may also spur new autoimmune disorders by suppressing immune function.

It’s important to weigh benefits and risks with your doctor, Mr. Longo said. Nondrug options like dietary changes can also help control IBD, he added.

Mr. Longo recommended IBD patients track their food. "[This] will help them understand which foods tend to aggravate their symptoms and which help,” he said. Combined with medications, healthy eating can help maintain IBD remission, he noted.