Biosimilars Versus Biologics for the Treatment of Psoriatic Disease

Similarities, Costs, and Access

Injectable medicine

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Biosimilar drugs are manufactured similarly to biologic drugs. Like biologics, they are derived from living cells (human, animal or bacterial) in a lab setting. Many people think biosimilars are generic versions of biologics. However, this is not the case, as it is impossible to accurately copy a drug made from living cells.

The difference between biologics and biosimilars of most interest to consumers is price. One of the main arguments for using biosimilars is the cost savings for both patients and insurance companies. For example, a 2017 report from the RAND corporation predicted that by 2026, biosimilars could reduce biologic spending in the U.S. by $54 million.

While biologic drugs are still being developed and going through the approval process, several biosimilars have been created to treat autoimmune diseases, including psoriatic disease. In 2016, the Food and Drug Administration (FDA) approved three biosimilars to treat plaque psoriasis and psoriatic arthritis. 

Relationship Between Biosimilars and Biologics

The FDA defines a biosimilar as a “biological product that is highly similar and has no clinically meaningful differences” compared to an existing FDA-approved biologic product.

Highly similar means the structure and function of the biosimilar product are the same as the original biologic product. No meaningful clinical differences mean the biosimilar has no differences in safety and effectiveness, as noted in clinical studies of the similar biologic.

Researchers model biosimilars after FDA-approved biologics to ensure they have the same effect on the immune system. They can also be administered in the same ways—either as a shot (injection) or an intravenous (IV) drip (infusion).

FDA-Approved Biosimilars

As of 2019, the FDA has approved three biosimilars for the treatment of psoriasis and psoriatic arthritis:

  • Biosimilars to the drug Humira (adalimumab): Amjevita (adalimumab-atto) and Cyltezo (adalimumab-adbm)
  • Biosimilar medicine to Enbrel (etanercept): Erelzi (etanercept-szzs)
  • Biosimilars to Remicade (infliximab): Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda)

Costs and Access

The price of each biosimilar drug will vary but patients can typically expect them to cost less than the biologic version. One reason for the cost difference is that biosimilar drugs are created by “reverse engineering” a biologic product.

While they still undergo a rigorous research, development, and testing process, it’s less than was required to make the original biologic drug. That’s why it generally costs less to produce a biosimilar than it did to create the biologic it was based on.

When medications are cheaper, they are more accessible to patients and reduce the overall economic toll. However, that's assuming that the biosimilar drugs exist, have been approved, and are available to consumers.

For example, people with psoriatic disease in the U.S. don't have access to some biosimilars available in Canada, Australia, and many European countries due to patent disputes that have held up the approval process.

Who Can Take Biosimilars?

Biosimilars are prescribed to treat advanced cases of a disease, including psoriatic conditions. You may need to take special steps to prevent infection when you are taking biosimilars, as your immune system won’t be as strong. For example, your doctor might instruct you not to get a “live” flu vaccine or avoid friends and family members who are sick.

If your doctor wants to prescribe a biosimilar to treat your moderate-to-severe psoriatic disease, you will need to be screened for tuberculosis (TB) and other infectious diseases before you can start the medication.

Specific biologics and biosimilars used to treat psoriatic conditions, such as Humira, provide a list of infections or conditions, such as fungal infections and tuberculosis, that patients taking the drug should watch for. If you develop these infections, you should not take biosimilar drugs.

If you are pregnant or nursing, you may need to stop taking a biosimilar drug. While some biosimilars might be safe if you are pregnant or breastfeeding, the research is limited. It's not yet clear how different biosimilars could affect fetal development, influence the course of pregnancy and delivery, or pass into breastmilk.

If you have psoriatic disease and take biosimilars, talk to your doctor if you plan to become pregnant.

Risks and Side Effects

The risks and side effects of biosimilars are the same as those associated with their biologic counterparts. If you are thinking about a biosimilar, you should talk to your doctor and weigh the risks and benefits of taking these medications.

Each biosimilar will have its own list of side effects, but some of the more commonly experienced include:

  • Headaches
  • Abdominal pain
  • Flu-like symptoms
  • Upper respiratory infections
  • Skin reaction where the injection was given/IV inserted

Let your doctor know if you experience side effects from biosimilars, especially if they persist after a few weeks of treatment.

One of the most significant risks of biosimilars and biologics is that they suppress your overactive immune system, which means you'll be at an increased risk for infections (some of which can be serious).

If you develop signs of infection when taking biosimilars or biologics, call your doctor right away.

Signs of Infection

  • Fever
  • Chills
  • Sweating
  • Swelling and soreness of the skin
  • Red skin that feels warm to the touch
  • Stuffy nose, chest congestion, feeling short of breath

Using Biosimilars With Other Treatments

Before starting a biosimilar or biologic, tell your doctor about all the medications, vitamins, and supplements you are currently taking.

Much like biologics, biosimilars are usually safe to use with topical treatments and phototherapy for psoriasis. However, research has suggested there are some cases when mixing treatments is not advised.

For example, a 2013 study found that using Inflectra (a biosimilar to Remicade) with phototherapy may increase skin cancer risk. 

Other drugs commonly used to treat psoriatic disease, such as methotrexate, have been found to be safe to take with biologics and biosimilars.

Any drug that interacts with a biologic should not be used with a biosimilar. Talk to your doctor about whether a biosimilar in conjunction with your other treatments is a good fit for you.

A Word From Verywell

If you are currently using a biologic, ask your doctor if there is a biosimilar to your current biologic available and if it could be a safe and effective option for you.

You should ask your doctor about how the biosimilar will be included as part of your treatment plan, and about safety, effectiveness, and cost. You will also want to find out if your insurance will cover the cost of a biosimilar. If it currently does not, ask when coverage will be available. 

As research continues and patent litigations are resolved, new biosimilars are expected to become available in the years to come. Once these drugs are approved and hit the market, you'll have more options for treating psoratic disease.

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Article Sources

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