Is Amjevita interchangeable with Humira?

Official answer

by Drugs.com

Amjevita is not yet interchangeable with Humira, and the pharmacist must get approval from your doctor before they can substitute it for Humira. To date, the only approved interchangeable biosimilar for Humira is Cyltezo, which was granted this status by the FDA in October 2021. Cyltezo will be commercially available July 1, 2023.

Additional interchangeable biosimilars for Humira are expected to be approved once reviewed by the FDA.

What is an interchangeable biosimilar?

An interchangeable biosimilar is a biologic product that can automatically be substituted for the reference product (in this case, Humira) by a pharmacist, depending upon state laws. Your pharmacist will not need to contact the doctor to get an approval.

It also means the reference biologic and the new biosimilar can be switched back and forth in a patient without a risk of changes in safety or effectiveness.

This is similar to how generic drugs are routinely substituted for brand-name drugs at the pharmacy. The manufacturer of a biosimilar must submit an application to the Food and Drug Administration (FDA) with enough required information comparing it to the reference product to support an interchangeability status.

Interchangeable products may make it easier for you to access a biologic medicine, because they should be more affordable and more likely to be covered by your insurance. Not all biosimilars are interchangeable, and interchangeable products are just starting to come to the market as of 2021.

If interchangeable status has not been approved by the FDA for a particular biologic, biosimilars can be dispensed in place of another biological product if the healthcare provider specifically prescribes the biosimilar product by name (and based on state laws).

What are Amjevita and Cyltezo?

Amjevita (adalimumab-atto) and Cyltezo (adalimumab-adbm) are both tumor necrosis factor (TNF) blockers that reduce the effects of a substance in the body that can cause inflammation.

Both biosimilars are FDA-approved to treat:

These products are given by subcutaneous (under the skin) injection, usually every 2 weeks. You or a caregiver can learn how to give this injection at home, as directed by your doctor.

Which biosimilars are interchangeable?

Interchangeable products approved by the FDA (as of June 2023) include:

A proposed biosimilar or interchangeable product is compared to and evaluated against a reference product to ensure that the proposed product is highly similar to, and has no clinically meaningful differences from, its reference product, according to the FDA.

Automatic substitution by a pharmacist can occur once a product is deemed as interchangeable by the FDA. If the product is listed as interchangeable, then it is biosimilar to the reference product and will produce the same clinical result.

Is Amjevita cheaper than Humira?

Yes, Amjevita is usually slightly less expensive than Humira if you are paying cash for your prescription. However, both of these medicines are very expensive, so if your insurance does not cover the cost, check with your doctor and insurance for alternatives, or contact the manufacturer (see below) to see if you qualify for financial assistance.

These prices are based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.

The cost of medicines when using commercial or government-sponsored insurance (for example, Medicare or Medicaid) may vary based on your pharmacy benefit, deductible and copay.

Some discount programs are for commercially insured patients only. Contact your insurance company to determine if these drugs are covered under your plan and what your share of the price may be. The manufacturer may be able to offer you a copay plan that could save you money.

The manufacturer may also be able to offer financial assistance to people who qualify for cost-free or discounted medicines, to individuals with low income or those who are uninsured or under-insured and meet specific criteria. Eligibility requirements for each program may vary.

The manufacturer of these drugs may offer copay or patient financial assistance to qualified patients. To learn more, contact:

How do I find out which biosimilars are interchangeable?

FDA-approved biological products that are designated as interchangeable can be found in The Purple Book. Your pharmacist can also tell you which biological products are interchangeable.

The Purple Book is the FDA resource for pharmacists and other health care providers interested in making an interchange between a reference biologic and a biosimilar.

To date, there are 41 biosimilars approved by the U.S. Food and Drug Administration (FDA), and 4 of these are interchangeable.

Is Cyltezo covered by insurance?

If you have OptumRx as a pharmacy benefit provider, your prescription for Cyltezo may be covered with a copay. It was added to their formulary as a preferred brand on June 23, 2023.

Other insurance companies may also cover Cyltezo, Humira or Amjevita. Check with your insurance plan for your specific benefits.