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.
What is a biosimilar medication?
A biosimilar is a biologic medication. It is highly similar to a biologic medication already approved by FDA – the original biologic (also called the reference product).
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.
Learn what biosimilars are, what they mean for patients, and how biosimilars can be a cost-saving alternative for patients in this National Consumer League podcast with Sarah Ikenberry, Senior Communication Advisor for the Office of Therapeutic Biologics and Biosimilars.
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
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.
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.
Source: https://www.fda.gov/drugs/biosimilars/biosimilars-basics-patients
