Biosimilars

Biosimilar medicines are a type of biologic drug, and may be administered via injections or intravenous infusion. Although biosimilars are modeled after an FDA-approved biologic medicine or biologic, they undergo different approval processes. The FDA can approve a treatment as a biosimilar or an interchangeable biosimilar. FDA standards ensure that biosimilars and interchangeable biosimilars are just as safe and effective as their biologic reference product.

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Relationship Between Biosimilars and Biologics

Biosimilars are highly similar to their biologic reference product. All biologics, including biosimilars:

Target specific parts of the immune system rather than impacting the entire immune system
Are given as an injection or IV infusion

To be approved as a biosimilar for a particular reference biologic, the biosimilar must be:

Highly similar to the reference product and cannot have any clinically meaningful differences in terms of safety or efficacy
Approved for the indication(s) and condition(s) for which the reference product is approved
Be given the same form and in the same dosage as the reference product

Keep in mind that biosimilars are not exact copies of their biologic reference product. Biologics are large and complex molecules from living sources that cannot be exactly copied.

Read the NPF Medical Board position statement on the use of biosimilars for psoriasis and psoriatic arthritis

Interchangeable Biosimilars

An interchangeable biosimilar must meet the biosimilar standard plus an additional standard that the treatment will produce the same clinical result as the reference product in any given patient. If a biosimilar is approved as interchangeable, a pharmacist may substitute it without letting your prescribing health care provider know, in some states.

Many considerations go into a treatment decision. Always speak with your health care provider about the potential risks and benefits of a treatment recommendation.

Current Biosimilars on the Market

There are currently biosimilars on the market based on the biologic drugs below:

Humira (adalimumab)

FDA-Approved Biosimilars

There are several biosimilars approved for the treatment of psoriasis and psoriatic arthritis (PsA). Although these have been approved by the FDA, your health care provider may not be able to prescribe these treatments yet. There are other biosimilars currently being developed and tested. These may be approved and available in the future.

Frequently Asked Questions

Who Can Take Biosimilars?

All biologics, including biosmilars, are typically prescribed for people with more advanced disease, including individuals with moderate-to-severe psoriasis and active PsA. But each of the three approved biosimilars are indicated for different groups within this population.

Consult your health care provider before taking a biosimilar if:

Your immune system is significantly compromised
You have an active infection

Screening for tuberculosis or other infectious diseases is required before starting treatment with all biologics, including biosimilars.

What Are the Risks of Biosimilars?

The risks and side effects of biosimilars are the same as those associated with their biologic reference product. Anyone considering taking a biosimilar should talk with their health care provider about the short- and long-term side effects and risks. It is important to weigh the risks against the benefits.

Biologics and biosimilars can increase the risk of infection. If you develop any sign of an infection, such as a fever, cough, or flu-like symptoms, you should contact your health care provider right away.

Can Biosimilars Be Used With Other Treatments?

It is important to tell your health care provider about all treatments, medicines, vitamins, or supplements that you are taking. Like all biologics, biosimilars can be used with other treatment options including topicals and phototherapy.

NPF Position Statement

The NPF Medical Board has published a position statement on the use of biosimilars for psoriasis and psoriatic arthritis.

Read the statement

Last updated on 5/11/2023 by the National Psoriasis Foundation.