Remicade vs. Biosimilars (Inflectra, Renflexis, Avsola)Specialty Infusion Blog September 29, 2021
If you take biologic medications like Remicade to treat a chronic inflammatory autoimmune condition, you’ve probably heard of biosimilars from your physician or other healthcare providers. Biosimilars can be complex to understand, leaving you with many questions.
We put together this comprehensive guide of common questions and answers to better understand the differences between Remicade and biosimilars.
(We always advise you to speak to your doctor before switching medications.)
What is a biologic medication?
Utilizing biotechnology, biologic medications are made from components that stem from human, animal or microorganism sources including sugars, proteins, DNA, whole cells, or tissue or other various elements of living things such as bacteria, birds, insects, mammals, and plants.
Since biologics come from diverse sources that can be hard to identify, they are more complex than conventional drugs. In addition, once these drugs are formed, they also tend to be more unpredictable in how they can take effect and are more sensitive to light and temperature.
With advances in the field of medicine, some biologics (gene-based and cellular) are now being used as treatments for many illnesses and diseases that may have previously otherwise had no treatment options available.
How do biologics work?
Depending on the disease and medication, biologics can:
- Help manage the immune system’s signals involved in the inflammatory process that can lead to joint tissue damage
- Target certain proteins that encourage inflammation, help cancer cells grow, or play a role in developing psoriasis.
- Stimulate the immune system helping it work more effectively to fight infection
What is Remicade?
Remicade (infliximab) is a biologic prescription used to treat chronic inflammatory autoimmune diseases by reducing the effects of substances in the body that can cause inflammation. These conditions include:
- rheumatoid arthritis
- psoriatic arthritis
- ankylosing spondylitis (chronic inflammation of the spine and the sacroiliac joints)
- plaque psoriasis in adults (severe or disabling cases)
- ulcerative colitis (patients at least six years old)
- Crohn’s disease (patients at least six years old)
This medication is given through intravenous infusions (IV), and dosage depends on the patient’s medical condition, weight, and response to treatment.
What are biosimilars?
Biosimilars are medications made using the same amino acid materials and specific processes as their reference drug. The reference drug refers to the well-tested, FDA-approved biologic drug that’s been on the market for years. The biosimilar presents with no significant differences in its safety or efficacy from the biologic product and is only available with a prescription from a healthcare professional.
The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was created as an “abbreviated licensure pathway” for biological products to :
- provide more treatment options
- increase access to lifesaving medications
- possibly lower health care costs through competition
Are biosimilars the same as generic drugs?
No, they are not. Unlike generic drugs, biosimilars are not identical copies of their reference drugs. However, each biosimilar drug is manufactured by a complex process that includes the exact steps that were made to make the biologic medication.
While the same process is followed, small changes are common from batch to batch since biosimilars are made from living cells. These variations are expected and acceptable because every lot is still required to meet the same high standards of purity, safety and efficacy as per the guidelines of the FDA.
What are the biosimilars to Remicade?
There are currently 3 FDA-approved biosimilars to Remicade in the United States; Inflectra, Reneflexis, and Avsola.
Inflectra was the first biosimilar to Remicade, manufactured by Pfizer and released in April 2016. Renflexis was approved in April 2017 and Avsola was approved in December 2019, though it is unavailable.
All three biosimilars belong to the class of drugs called tumor necrosis factor (TNF) alpha inhibitors and work similarly to block TNF-alpha proteins that cause inflammation and swelling. Like Remicade, they are also given through an IV injection.
Inflectra, Renflexis, and Avsola are used to treat the same conditions as Remicade, including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, and plaque psoriasis.
These biosimilars are commonly used when other treatment options haven’t worked and can cost less than Remicade.
At this time, Inflectra, Renflexis, and Avsola aren’t considered “interchangeable” by the FDA, meaning a pharmacist can’t switch someone from a biologic to a biosimilar without a prescription from a physician/healthcare provider. If you are currently on Remicade, and it’s not working, you may want to speak with your doctor about biosimilar options.
At Speciality Infusion Centers, we specialize in managing chronic conditions and work with you, your insurance carrier, and your healthcare doctor to provide a personalized treatment plan. Find the most convenient location for you to start on your Remicade, Inflectra, or Renflexis IV therapy today.