New Biosimilar Approved for Humira

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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We have good news for your health wallet! Humira (adalimumab), a popular specialty medication used to treat rheumatoid and psoriatic arthritis, will soon have a less expensive alternative, Amjevita (adalimumab-atto).

Amjevita is a “biosimilar” to Humira (because biologic drugs like Humira can’t have traditional generic alternatives), and will be offered at a reduced cost. Amjevita is now the 1st FDA approved biosimilar for Humira, the 2nd biggest selling drug of 2015.

If you are not sure what a biosimilar is (don’t worry, you’re not alone) check out one of our previous blog posts about biosimilars here.

Can Amjevita be used for all the same indications as Humira?

Unfortunately, no. Humira has been approved for 10 conditions, whereas Amjevita has only been approved for 7 conditions, listed below:

  1. Pediatric patients 4 years of age and older with moderate to severe active polyarticular juvenile idiopathic arthritis.
  2. Moderate to severe active rheumatoid arthritis.
  3. Moderate to severe active Crohn’s disease (adult).
  4. Moderate to severe active ulcerative colitis.
  5. Adults with chronic moderate to severe plaque psoriasis.
  6. Active ankylosing spondylitis (arthritis of the spine).
  7. Active psoriatic arthritis.

What are the other 3 indications that Humira was approved for?

Amjevita is not approved for the following conditions:

  1. Uveitis
  2. Hidradenitis Suppurativa
  3. Pediatric Crohn’s disease

What type of cost-savings will Amjevita offer?

Amgen, the manufacturer of Amjevita, did not discuss the price of the drug in its recent press release. However, based on previous biosimilar cost savings, you can expect a discount of around 15%-30% of the cost of Humira.

What dosage forms and strengths will Amjevita be available as?

Amjevita comes in a single use pre-filled syringe in both 20mg/0.4ml and 40mg/0.8ml strengths, and a single-use pre-filled sureclick autoinjector in a 40mg/0.8ml strength.

How will Amjevita be administered?

Amjevita should administered by subcutaneous injection every week, or every other week. The dosing will be different for each individual based on the diagnosis.

If the doctor writes for Humira, can the pharmacy fill Amjevita instead?

Unfortunately, no. This is where biosimilars differ from regular generics. Amjevita is a biosimilar, not an interchangeable product. Interchangeable products are usually generic medications that can be substituted for a brand name medication without needing to consult the prescriber.

When was Amjevita approved by the FDA?

Amjevita was approved by the FDA on September 23rd, 2016. There is currently no estimate for when it will be available in pharmacies.

What are the common side effects of Amjevita?

The most common side effects include infections, and redness, swelling, or itching at the injection site.

Want to read more about Amjevita?

Take a look at the FDA announcement for Amjevita’s approval here.

You can also check out the manufacturer website here.

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