Biologics vs. Biosimilars
Biologics are expensive medications. Biosimilars offer the option of taking a copy of the biologic but at a more affordable price. Here’s a closer look at the difference between biologic medications and biosimilars.
What are biologic drugs?
Biologic medications are created from living cells of organisms. They work by targeting specific cells, proteins and pathways in the immune system that cause inflammation in the body.
Biologics bind to the cells and interrupt how they function. They can inhibit cell growth and block proteins called cytokines that lead to inflammation in the airways or on the skin. In effect, the medications can stop symptoms before they can start.
What are biosimilar drugs?
A biosimilar medication is a copy of a biologic drug, with only minor differences. Biosimilars provide the same benefit as the biologic brand-name drug. The Food and Drug Administration (FDA) makes sure that biosimilars are safe and work well. A biosimilar should have the same effect on a patient as the brand-name biologic.
Biosimilars are approved for a host of medical conditions. These include respiratory conditions such as asthma and allergies, skin conditions such as eczema and chronic urticaria, rheumatoid arthritis, and cancer treatment.
What is the difference between biologics and biosimilars?
Biologics must be approved by FDA. Biosimilars are then made based on the original biologic. The active ingredients are the same. There may be some inactive ingredients that differ between the two, but they are minor. Patients experience the same effect taking biosimilars as they do when taking biologics.
The primary purpose of biosimilars is to make the biologic treatment more accessible and affordable.
What do the differences mean for patients?
People who are prescribed biosimilars typically pay less than they would for a brand-name biologic.
Biosimilars increase access to potentially life-saving medications. They are especially helpful to communities that are underserved, including people on low income.
Why are biosimilars made?
Biosimilars increase access to medications that serve the same purpose as biologics. They offer more affordable treatment options and offset rising drug prices, especially to communities that are underserved and low-income families. Biosimilars can also lower healthcare costs through competition.
Why are biologics more expensive than biosimilars?
The development process for biologics is expensive. It takes years of research and clinical trials before biologic medicines can be submitted to FDA for approval. All of this can add to the cost of biologics.
The approval process for biosimilars is shorter and therefore does not cost as much. Biosimilars must go through a process to show how similar they are to the original biologic. This makes biosimilars cost less than the original biologic.
What is biosimilar interchangeability?
The active ingredients in both biologics and biosimilars are the same. There may be some minor differences in the clinically inactive components. So you can use a biosimilar instead of the brand-name biologic and get the same drug effect. This is called “interchangeability.”
How can I find a biosimilar?
If your doctor recommends a biologic medication, ask if there’s a biosimilar available for it. FDA has a list of approved biosimilars for a variety of conditions. The information includes:
- the name of the biosimilar;
- the original biologic or reference drug;
- the date it was approved;
- links to more information, if applicable.
What’s the difference between generic and biosimilar drugs?
Generic drugs and biosimilars are both copies of brand-name drugs. The dosage form of the generic drug and the biosimilar is the same. Both cost less than their brand-name drug counterpart.
Generics are for medications made synthetically through chemical processes. Biosimilars are for biologic medications made from living organisms.
Generic medicines have a streamlined FDA approval process. Biosimilar drugs undergo a stricter approval process that may take more time.
Generic versions usually come in pill, tablet or liquid form. Biosimilars are given as an injection or infusion.
Are biosimilars safe?
Yes. Biosimilars must be as safe as their reference biologic counterpart. There should be no clinically meaningful differences between the two. The list of potential side effects is the same.
Are biosimilars specialty drugs?
Yes. Biosimilars are considered specialty drugs and are available at specialty pharmacies. These pharmacies are trained to handle and manage biologic products.
Are biosimilars as good as biologics?
Biosimilars are as safe and effective as their reference biologics. They provide the same treatment benefits. The list of potential side effects is the same.
What is the FDA process for biosimilar medicines?
FDA has a shorter approval process for biosimilars. Biosimilars must go through an approval process to show how similar they are to the original biologic. They must produce the same clinical results as its branded biologic. This includes no differences in safety and potency.
Are biosimilars covered by insurance?
Many insurance plans cover biosimilar medicines. But insurance coverage may vary between health plans. Some may consider biosimilars a preferred medicine, others may not. This may depend on the biosimilar, the condition it treats, and how long it has been approved. Talk to your insurance company and find out what is covered and what is not covered.
How much will insurance cover for a biosimilar?
Insurance coverage of biosimilar medicines may vary between health plans. Talk to your insurance provider about your coverage and treatment options.
