Enbrel generic availability, cost, and dosage

Enbrel is a prescription medication that contains the active ingredient etanercept. It is administered by subcutaneous injection (injection under the skin). Enbrel is a member of a drug class called tumor necrosis factor blockers, or TNF blockers. It works by blocking the effects of tumor necrosis factor, which is a chemical messenger that causes inflammation. Enbrel is approved by the Food & Drug Administration (FDA) to treat the following:

• Moderate to severe rheumatoid arthritis in adults, alone or in combination with methotrexate
• Moderate to severe polyarticular juvenile idiopathic arthritis in pediatric patients 2 years and older
• Psoriatic arthritis in adults, alone or in combination with methotrexate
• Juvenile psoriatic arthritis in pediatric patients 2 years and older
• Ankylosing spondylitis in adults
• Moderate to severe plaque psoriasis in adults and children 4 years and older

Brand-name drugs can be costly. For people who pay out of pocket with no insurance coverage or discounts, a one-month supply of Enbrel costs about $8,431. That’s more than $101,000 per year. Because of these high prices, patients who take Enbrel may want to know if a lower-cost generic is available. In the case of Enbrel, however, any lower-cost alternatives would be considered biosimilars, not generics.

What are biosimilars?

Enbrel is a biologic drug, meaning it comes from natural sources like animals or humans and may be produced using biotechnology. According to the FDA, biologics are complex mixtures that cannot be easily characterized or identified, whereas nonbiologic drugs are made with chemicals and have a known structure. Biologics do not have generic formulations, but instead, they may have what’s called a biosimilar drug. 

When we refer to prescription and over-the-counter drugs, we know that there are brand and generic drugs. For example, your healthcare provider may prescribe Lipitor to treat high cholesterol, and your pharmacist may dispense atorvastatin, which is generic Lipitor.

However, when we discuss biologic medicines, the original drug—such as Enbrel—is called a reference product. A biosimilar is an almost identical copy of the approved biologic drug, or reference product. 

Because biologics are complex, a biosimilar cannot be exactly the same as the reference product. However, a biosimilar must contain the same ingredient, work the same way, and have the same mode of administration (such as injection) and dosing as the reference product. Before being FDA approved, biosimilars are clinically tested to ensure they are as safe and effective as the reference product. Even after they are approved, biosimilars undergo ongoing monitoring.

Interchangeability is an FDA designation that means the biosimilar can be automatically substituted (is considered interchangeable) for the reference product. Like the Lipitor example above, if a biosimilar is designated as interchangeable, that specific biosimilar can be dispensed by the pharmacy in place of the reference product if allowed by state law. However, not all biosimilars are approved as interchangeable. 

Note that the ingredient in Enbrel is called etanercept. Every Enbrel biosimilar will be called etanercept, but with a four-letter suffix after the name. These letters differentiate biosimilars from the reference product. If the letters seem random, that is because the FDA has certain guidelines for these suffixes. For example, the four unique lowercase letters cannot have any specific meaning. For example, if the drug company Teva makes a biosimilar, the last four letters cannot be -teva. 

Enbrel biosimilars

Two Enbrel biosimilars have been FDA approved, but they are not yet available on the market. Both are biosimilars but do not have an interchangeable designation:

• Erelzi (etanercept-szzs): This biosimilar was approved in August 2016. It is expected to be available in 2029.
• Eticovo (etanercept-ykro): This biosimilar was approved in April 2019 and is also expected to be available in 2029.

Other important information about Enbrel

Here are some other things you should know about Enbrel:

• Before you take Enbrel, tell your healthcare provider about all of your medical conditions and medical history, including if you are pregnant or breastfeeding. Read the medication guide that you receive with your prescription and ask your healthcare provider if you have any questions.
• Enbrel has a boxed warning, also called a black box warning, which is the most serious warning required by the FDA. Because Enbrel affects the immune system, there is an increased risk of serious infections, which can cause hospitalization or death. These may include tuberculosis (TB) or other types of bacterial, fungal, or viral infections. Your healthcare professional will test you for TB before you start Enbrel and monitor you for TB and other infections during treatment. People with serious infections or sepsis should not take Enbrel. The warning also states that there is an increased risk of lymphoma and other malignancies (cancers).
• Before taking Enbrel, you should tell your healthcare provider about all the medications you take, including prescription drugs, OTC medicines, vitamins, and supplements, so they can check for drug interactions. While taking Enbrel, you should not get live vaccines, such as MMR, rotavirus, varicella (chickenpox), or the nasal flu vaccine. You should not take Enbrel with Orencia (abatacept) or Kineret (anakinra) because of an increased risk of serious infections. You should not take Enbrel with cyclophosphamide.
• The most common side effects of Enbrel include infections and injection site reactions.
• Other Enbrel side effects, including serious side effects, may occur, including heart failure or worsening of existing heart failure, hepatitis B reactivation or other liver problems, nervous system problems, and allergic reactions. Consult your healthcare provider for a full list of side effects. 

How to save money on Enbrel

Until there is an Enbrel biosimilar available, here are some tips for saving money on your medication: 

• Use a SingleCare prescription discount coupon or card. The average out-of-pocket cost for a one-month supply of Enbrel is $8,431, but you can pay $6,508 per month with an Enbrel SingleCare coupon. That’s a savings of $1,923 per month and $23,076 per year. Ask your pharmacist to check your SingleCare discount to see how much money you can save.
• Look into the manufacturer’s copay card. Eligible patients with commercial insurance may sign up for the Amgen SupportPlus Co-Pay Card and get Enbrel for free. Check with the manufacturer for more information and eligibility requirements.
• Find out if you are eligible for assistance through the Amgen Safety Net Foundation. This foundation provides free Amgen medication to patients with financial need.
• If you have Medicare prescription coverage but need help paying for your prescriptions, look into the Extra Help program. This program helps people with limited income and resources lower their prescription costs, such as deductibles and copays. You can apply for Extra Help at any time through the Social Security Administration.

RELATED: Does Medicare cover Enbrel?

• If you have tried all the options, and your price for Enbrel is still high, consult your healthcare provider about trying a different medication that is effective and affordable. There are various options that you can try, and your healthcare provider will work with you to find the best medicine to treat your condition.

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