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
• The same mechanism of action as the reference product, which means it works the same way in the body

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.

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.

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

FDA-Approved Biosimilars

There are now several biosimilars approved for the treatment of psoriasis and psoriatic arthritis (PsA):

• Amjevita (adalimumab-atto), Abrilada (adalimumab-afzb), Cyltezo (adalimumab-adbm), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp) and Hyrimoz (adalimumab-adaz) are biosimilar medicines to Humira (adalimumab)
• Erelzi (etanercept-szzs) and Eticovo (etanercept-ykro) are biosimilar medicines to Enbrel (etanercept)
• Avsola (infliximab-axxq), Inflectra (infliximab-dyyb), Ixifi (infliximab-qbtx) and Renflexis (infliximab-abda) are biosimilar medicines to Remicade (infliximab)

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.

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.

You should not take biosimilars 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 act on cytokines, which are specific proteins released by the immune system that can cause inflammation. Biologics suppress the function of the overactive immune system. When on a biologic or biosimilar, you may have a higher risk of infection. If you develop any signs of an infection, contact your health care provider right away.

Signs of infection include:

• Chills
• Damp, sticky feeling or sweating
• Fever
• Nasal (nose) or chest congestion
• Pain or burning when urinating
• Shortness of breath
• Skin redness, swelling, soreness, or warmth

The impact of biologics on developing fetuses or nursing infants is not known. Biologics should only be prescribed to pregnant or nursing women if there is a clear medical need.

Common side effects of biosimilars may include:

• Abdominal pain
• Flu-like symptoms
• Headache
• Injection site reactions
• Upper respiratory infections

Call your health care provider if you are experiencing any side effects with biosimilars.

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. The biologics Enbrel, Humira, and Remicade are shown to be safe and effective when taken with methotrexate. This means their biosimilars, including Erelzi, Amjevita, and Inflectra, may be safe and effective when taken with methotrexate.

• With Inflectra being the biosimilar to Remicade, its use in combination with phototherapy may increase the risk of skin cancer.
• No drugs that interact with biologics should be combined with their respective biosimilars.

Last updated on 3/10/2023 by the National Psoriasis Foundation.