Inflectra Becomes the Second Biologic Approved in the US

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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New Biosimilar Approval: Inflectra
Inflectra (infliximab-dyyb) is the second biosimilar to be approved in the US—hopefully with more to come in 2016.

Inflectra will be an alternative offered at a lower cost (similar to a generic drug) than its “reference biologic product” (similar to a brand-name drug). Like brand-name Remicade (infliximab), Inflectra will be use to treat several inflammatory conditions, include Crohn’s disease, arthritis, and psoriasis.

What is a biosimilar drug?

A biosimilar is basically a very similar product to a type of medication known as a biologic. Biologic medications are typically made from a living organism including humans, animals, microorganisms, or yeast.

Unlike regular brand and generic alternatives though, your pharmacist can’t automatically substitute a biosimilar for the original product. Your doctor will need to write a new prescription for Inlfectra if you already take Remicade.

For more information on biosimilars, see our previous post here.

What is Inflectra used for?

Like Remicade, Inflectra is used for several conditions, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis, ankylosing spondylitis (arthritis of the spine), and psoriatic arthritis.

Unlike Remicade, Inflectra does not have approval to treat pediatric ulcerative colitis as this time.

What are the side effects of Inflectra?

The most common side effects of Inflectra include respiratory infections, sore throat, headache, cough, stomach pain, and reaction to the infusion.

What kind of savings will Inflectra offer?

There isn’t much information on Inflectra pricing in the US yet. However, in the United Kingdom where Inflectra is already available, Inflectra costs about 10% less than Remicade.

Inflectra has been available in Europe since 2013, offering patients a cost-effective alternative to Remicade while maintaining the same quality, safety, and efficacy.

How is Inflectra used?
Inflectra is given by your healthcare provider as an intravenous infusion. Dosing is weight-based, and different for each person based on your diagnosis.

If the doctor writes for Remicade can the pharmacist substitute with Inflectra?

No. Inflectra is a biosimilar NOT an interchangeable product like a regular generic.

Generic medications can be substituted for a brand name medication, without needing to consult your doctor. However, biosimilars like Inflectra require a new prescription.


Want more info?

See the FDA announcement here.

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