Biosimilars: what patients need to know
- A biosimilar and its original biologic are made from the same types of sources – and have the same treatment risks and benefits.
- Biosimilars are a type of biologic medication that is safe and effective for treating many illnesses.
- A biosimilar and its original biologic have the same treatment risks and benefits.
- Biosimilars may be available at a lower cost than the original biologics.
View “Biosimilars: What Patients Need to Know” infographic.
What is a biosimilar medication?
Biosimilars also have no clinically meaningful differences from the reference product. This means you can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would the reference product.
Biosimilars are made from the same types of sources (e.g., living cells or microorganisms) and are just as safe and effective as their reference products.
What are biologic medications?
Biological products (also called biologics) can be made of sugars, proteins, living cells, tissues, or a combination of these. They are made from natural and living sources like animal and plant cells, and microorganisms such as bacteria or yeast.
Biological medications are usually more complex than other drugs. They are often more complicated to purify, process, and manufacture.
A biosimilar is very similar, but not identical, to an original biologic medication.
For biosimilars to be approved by FDA, studies must show that there are no differences in the safety and effectiveness of biosimilars and the original biologics.
Both a biosimilar and its original biologic:
- Are made from the same types of sources (e.g., living sources).
- Provide the same benefits when treating diseases or medical conditions.
- Are given at the same strength and dosage.
- Are not expected to cause new or worsening side effects.
Is your medication available as a biosimilar?
As with all treatment decisions, you should talk to your healthcare providers and check other trusted sources of information related to your specific condition to learn more about biosimilar treatment options.
Biosimilars are safe and effective.
They are used for the treatment of many chronic and severe conditions, including:
Chronic skin diseases (such as psoriasis)
Chronic bowel diseases (such as colon, Crohn's disease, and irritable bowel disorder)
Some cancers (such as, breast, lung, and colon)
The regulation of insulin as a biologic allows multiple companies to make biosimilar versions of “brand name” insulins, similar to how generics are versions of brand name drugs.
View “Biosimilars: What Patients with Diabetes Need to Know” infographic.
FDA makes sure biosimilars are as safe and effective as the original product by:
- Approving biosimilars after a careful review of data, studies, and tests.
- Monitoring safety and effectiveness after approval.
- Checking for medication quality during production.
- Reviewing patient safety reports made to FDA.
A biosimilar and its original biologic have the same treatment risks and benefits.
Compared with their original biologics, biosimilars:
- Are made with the same types of natural sources.
- Are given the same way.
- Provide the same treatment benefits
- Have the same potential side effects.
- Have the same strength and dosage.
A patient might switch to a biosimilar because of a change in insurance coverage or to save money.
Similar to generic drugs, biosimilars may cost less because manufacturers rely on FDA’s finding that the original biologics are safe and effective.
The lower cost is not a reflection of effectiveness or safety of biosimilars. Because of the lower cost, biosimilars may be covered by more insurance companies and offer patients additional treatment options.
Frequently Asked Questions
Because most biologics are made from living sources, it is normal for both biosimilars and original biologics to have minor differences between batches of the same medication. This means that biologics cannot be copied exactly, and that is why biosimilars are not identical to the original biologic.
FDA carefully reviews the differences between the original biologic and the biosimilar to ensure that biosimilars are as safe and effective as the original biologics.
An interchangeable product is a biosimilar that may be substituted without consulting the prescribing doctor, because it meets additional requirements related to the potential for automatic substitution. This practice is called “pharmacy-level substitution” and is subject to state law.
Both biosimilars and interchangeable biosimilars are as safe and effective as the original product they were compared to.
A biosimilar is not safer or more effective than the original biologic, but a patient might switch to a biosimilar because of a change in insurance coverage or to save money. Depending on the law in your state, a pharmacist may give you an interchangeable biosimilar, much like they would give you a generic. FDA does not control the cost of drugs, but you can learn more about the price of a specific biosimilar by contacting your pharmacy or insurance company.
Generally, biosimilar medications can be used whether or not you have been treated first with the reference product. Always talk to your health care provider about available treatment options and potential risks and benefits.
Talk to your health care provider about the medications you are prescribed or are taking. Often, biological medications, including biosimilars, are given in a hospital or an infusion center. Talk to the doctor or nurse who is giving you the treatment. If you have a prescription, your doctor or pharmacist can tell you what you are prescribed and what you are given at the pharmacy.
Biosimilars are like generics in some ways, in that, both types of medications are compared to a reference (original) product for approval. Biosimilars and generics are both versions of previously FDA approved medications and may offer more affordable treatment options to patients.
Biosimilars and generics are approved through different abbreviated pathways that avoid duplicating certain costly clinical trials.
Both biosimilar and generics go through a rigorous review process. Once FDA-approved, these medications are just as safe and effective as the reference products they are compared to. But, there are differences between biosimilars and generic drugs. For example, biosimilars are generally made from natural and living ingredients and generics are often made from chemical ingredients.
In contrast to a chemical, which is synthesized and can be generally copied, a biologic medication is made from natural and living sources and cannot be exactly copied. So, the information needed to demonstrate that a biologic is biosimilar to another biologic can be much more extensive than what is needed for a generic.
Reducing costs is one reason Congress created the FDA approval pathway for biosimilar medications. However, FDA does not regulate whether insurance companies cover or reimburse the cost of biosimilars. If you have insurance, check with your insurance provider to find out what’s included in your plan. If you are covered by Medicare or Medicaid, the Centers for Medicare & Medicaid Services (CMS) and plan providers can generally provide this information.
Frequently Asked Questions for Patients with Diabetes
Although insulin is made in living cells, it was historically regulated as a drug made from chemicals. Insulin and other drugs that meet the criteria for a biologic are now regulated as biologics. This does not change the ingredients of insulin or how you obtain medication at the pharmacy.
The most noticeable change is that patients can be prescribed a variety of additional insulin options once they are available, possibly at a lower cost, depending on your insurance coverage. Depending on the state law, a pharmacist may give you an interchangeable biosimilar insulin, much like they would substitute a generic for a brand-name drug. FDA does not control the cost of drugs, but you can learn more about the price of a specific biosimilar by contacting your pharmacy or insurance company.
Biosimilars: What Patients With Diabetes Need to Know
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Biosimilar Medications — What Patients Need to Know
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