FDA Approves Second Humira Biosimilar

a doctor's prescription pad
Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Cyltezo (adalimumab-adbm) is the newest biosimilar for the second biggest selling drug of 2015 – Humira. This is the second biosimilar for Humira, coming after the approval of Amjevita in 2016. 

What is a biosimilar?

Without getting too technical, biosimilars are basically the generic product of a biologic (a medication made from a living organism). However, because these medications are made out of living cells they are slightly different. The good news about biosimilars is that they are typically 15%-30% less expensive than their reference drug.

For more information about biologics and biosimilars, read our blog here.

What is Cyltezo indicated for?

Cyltezo is approved for the following 7 conditions:

  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 adult Crohn’s disease
  4. Moderate to severe active ulcerative colitis
  5. Moderate to severe plaque psoriasis
  6. Active ankylosing spondylitis (arthritis of the spine)
  7. Active psoriatic arthritis

Keep in mind that Cyltezo is only approved for 7 indications whereas Humira has 10 indications. These three indications that Humira also treats include uveitis, hidradenitis suppurativa, and pediatric Crohn’s disease. 

How will Cyltezo be sold?

Cyltezo will be available in a single-use prefilled glass syringe in the dosage of 40 mg/0.8 ml. The manufacturer, Boehringer Ingelheim, will also seek approval for an auto-injector in the future.

Cyltezo is to be administered by subcutaneous injection every week, or every other week. Dosing of Cyltezo is different for each individual based on diagnosis.

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What are the most common side effects of Cyltezo?

The most common side effects include infections, injection site reactions, headache or rash.

What is the difference between Cyltezo and Amjevita?

Although these two are both biosimilars for Humira, they are different. Amjevita will be available additionally in a single-use prefilled glass syringe in the 20 mg/0.4 mL strength as well as a SureClick autoinjector in the 40 mg/0.8 mL strength.

Is Amjevita currently available?

Unfortunately no, although Amjevita has been approved by the FDA, it is currently tied up in court (along with Cyltezo) with AbbVie, the manufacturer of Humira.

How much will Cyltezo cost?

Boehringer Ingelheim did not discuss the price of the drug in its recent press release. Like we mentioned above, Cyltezo prices could be as much as 30% lower than Humira.

Can the pharmacy substitute Humira for Cyltezo?

No. Although Cyltezo is a biosimilar, it is not interchangeable.

Interchangeable products are usually known as generic medications and can be substituted for a brand name medication if available and without needing to consult the prescriber.  Your doctor must write your prescription for Cyltezo if this is the medication that is intended for you to use.

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