FDA Approves Hyrimoz, the Third Biosimilar 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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The FDA just approved Hyrimoz, manufacturer Sandoz’s new biosimilar for the blockbuster rheumatoid arthritis drug, Humira.

This is the third Humira biosimilar to be approved by the FDA. Back in 2016, the FDA approved Amjevita, followed by Cyltezo in 2017. Unfortunately, none of these biosimilars are available in pharmacies yet, and may not be for a couple more years—likely until 2023 for Hyrimoz.



What is a biosimilar?

A biosimilar is technically the “generic” version of a biologic (a medication made from a living organism). However, because biologics are made out of living cells, they are impossible to replicate exactly. Biosimilars are less expensive versions of their reference biologic drugs, but the two aren’t interchangeable like generic drugs and their brand-name counterparts are.

You can read more about biologics and biosimilars here.


What is Hyrimoz for?

Hyrimoz is approved for seven of the 10 conditions that Humira treats:

Unlike Humira, Hyrimoz is not indicated to treat uveitis, hidradenitis suppurativa, nor pediatric Crohn’s disease.



How much will Hyrimoz cost?

Sandoz, the manufacturer of Hyrimoz, has not yet released the price of Hyrimoz. However, in general, biosimilars cost roughly 15% to 30% less than their reference drug. In this case, Humira costs more than $5,000 a month, while Hyrimoz could cost nearly $1,500 less. Unfortunately, that’s still expensive.


How should I take Hyrimoz?

Hyrimoz will be available as a 40 mg/0.8 ml single-dose syringe, and a 40 mg/0.8 ml single-dose SensoReady pen. Dosing will be different for each individual based on the diagnosis but will require a subcutaneous injection every week or every other week.


What are the most common side effects of Hyrimoz?

Common side effects of Hyrimoz include infections, injection site reactions, headache and rash.


Can the pharmacy substitute my prescription for Humira with Hyrimoz?

No. Hyrimoz is similar to Humira, but they’re not interchangeable at the pharmacy. Brand-name medications can only be substituted with their generic counterpart at the pharmacy without needing a consultation from your doctor.

Your doctor must write your prescription for Hyrimoz if you intend to use it over Humira.


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