Moderate to Severe Psoriasis and Psoriatic Arthritis: Biosimilar Medicines
Biosimilar medicines are a type of biologic drug. Biologics are derived from living cells (such as human, animal, or bacterial cells) in a laboratory. Some are given by injection (shot), and others are given by intravenous (IV) infusion (a slow drip of medicine into your vein).
Relationship between biosimilars and biologics
Biosimilars are modelled after an already FDA-approved biologic medicine or biologic (also called the “reference product”). There is a different approval process for biosimilars compared to other medicines. 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.
Biosimilars are highly similar to their biologic reference product in many ways. 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
- Have 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 (replace or switch) it without letting your prescribing health care provider know, in some states.
However, 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.
There are now three biosimilars approved for the treatment of psoriasis and psoriatic arthritis:
- Amjevita (adalimumab-atto) and Cyltezo (adalimumab-adbm) are biosimilar medicines to Humira (adalimumab)
- Erelzi (etanercept-szzs) is a biosimilar medicine to Enbrel (etanercept)
- Inflectra (infliximab-dyyb) 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 psoriatic arthritis. 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 (TB) or other infectious diseases is required before starting treatment with all biologics, including biosimilars.
What are the risks?
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.
Your immune system normally works to protect the body from illnesses and infections. When you have psoriasis or psoriatic arthritis, your immune system is overactive. This causes inflammation and speeds up how fast skin cells grow.
Biologics and biosimilars act on cytokines, which are specific proteins released by the immune system that can cause inflammation. Biologics suppress (lower) 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:
- Damp, sticky feeling or sweating
- 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 for biosimilars may include:
- Abdominal pain
- Flu-like symptoms
- Injection site reactions
- Upper respiratory infections
Call your health care provider if you are experiencing any side effects with biosimilars. For specific side effect information, download the individual product fact sheet.
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 that 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 for skin cancer.
- No drugs that interact with biologics should be combined with their respective biosimilars.
Speak with your health care provider about whether using biosimilars in combination with other treatments is right for you.
Do you have additional questions about biosimilars?
NPF’s Patient Navigation Center is the world's first, personalized support center for psoriatic disease. Our Patient Navigators can answer your questions about biologics and biosimilars, including understanding their side effects and helping assess potential risks. For free and confidential assistance, contact our Patient Navigators »