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. Some of these medications are given by injection and others are given by intravenous (IV) infusion (a slow drip of medication through a vein).  Many people think biosimilars are generic versions of biologics. However, this is not the case, because it is impossible to accurately copy a drug made from living cells.

There are several biosimilars available for treating a variety of autoimmune diseases, including psoriatic disease, an autoimmune disease that causes inflammation of skin and joints throughout the body. In 2016, the U.S. Food and Drug Administration (FDA) approved three biosimilars for the treatment of plaque psoriasis and psoriatic arthritis. One of the strongest arguments for biosimilar use is the cost savings to both patients and insurance companies.

Relationship Between Biosimilars and Biologics

The FDA defines a biosimilar as a “biological product that is highly similar and has no clinical meaningful differences” compared to an existing FDA-approved biologic. Highly similar means the structure and function of the biosimilar are the same as the "similar" biologic. No meaningful clinical differences means 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. They are considered similar in the way they target similar parts of the immune system and in how they are administered—by injection or IV infusion.

Biosimilars also affect the immune system in the way biologics do. In addition to similar safety and efficacy, biologics and biosimilars are approved for the same conditions and given in the same form and dosage.

FDA-Approved Biosimilars

In the United States, the FDA has approved three biosimilars for the treatment of psoriasis and psoriatic arthritis.

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

Costs and Access

Costs for biosimilars are believed to be up to 50 percent less than the cost of biologics. When medications are cheaper, they are more accessible to people with psoriatic disease and they also reduce economic costs.

These drugs are cheaper because they have not gone through the same research and development of biologics. That means the drug manufacturers save money because they don’t have to go through all the steps that biologic manufacturers did. The costs are then transferred to the consumer and insurance companies.

Unfortunately, many people with psoriatic disease in the United States do not have access to biosimilars yet. While biosimilars are available worldwide, including in Canada, Australia, and many European countries, there have been many patent disputes in the United States that are holding up the approval of biosimilars.

There is some evidence suggesting Pfizer’s Inflectra has managed to reach consumers. Other biosimilars are being currently being tested and developed and will likely be available in the near future.

Who Can Take Biosimilars?

Biosimilars are prescribed for people with more advanced disease, including people with psoriatic disease. However, some people should not take biosimilars. These include people with a significantly compromised immune system and anyone with an active infection.

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

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 about weighing the risks and benefits of these medicines.  

One of the most significant risks of biosimilars and biologics is that they suppress your overactive immune system. That means you will have a higher risk of infection. If you develop signs of infection when taking biosimilars or biologics, you should get in touch with your doctor right away.

Signs of infection include:

  • Chills
  • Sweating
  • Fever
  • Nasal and/or chest congestion
  • Shortness of breath
  • Skin redness, swelling, soreness and/or warmth

Biologics and biosimilars are not recommended for pregnant or nursing mothers if there is no medical need because the impact of these drugs on these groups is not known.

Additional side effects of biosimilars include:

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

Call your doctor if you experience side effects especially if these continue after a few weeks of treatment.

Using Biosimilars With Other Treatments

Before starting a biosimilar or biologic, you should tell your doctor about all medications, vitamins, and supplements you are currently taking. Much like biologics, biosimilars can usually be used with topical treatments and phototherapy, light therapy for the treatment of psoriasis. However, because Inflectra is a biosimilar to Remicade, using it with phototherapy may increase skin cancer risk

Biologics and biosimilars are both safe and effective when taken with methotrexate, an immunosuppressant drug. 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 and you want to know whether a biosimilar is an option for you, talk to your doctor about whether there is a biosimilar to your current biologic available and if it may be a good fit for you.

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

There will be more biosimilars coming onto the market in the coming years. Many have already been approved but are currently tied up in litigation. Regardless, many of these will be available soon and you will have more options for treating psoriatic disease.

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