BIOSIMILARS 101
In 2015 the first biosimilar was approved in the U.S., and there are more than 100 biosimilars either approved or on the way. Everyone involved—health care providers, payers, regulators, policymakers, patient advocates, and patients—needs a source of clear, unbiased, evidence-based information to better understand biosimilars and make wise decisions on policy and use.
This overview covers what biosimilars are, how they may be developed and manufactured, the regulatory procedures around approval and use, and how they will be used to expand treatment options for U.S. patients. The FAQs contain answers to the most common questions people have about biosimilars.
Top Three Reasons Biosimilars Are as Safe as Reference Biologics
Physicians, pharmacists and patients can be confident that the U.S. regulatory pathway for biosimilars ensures the following:
BIOSIMILARS BASICS FOR PATIENTS
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.
What are biologic medications?
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.
Biosimilars are safe and effective. They are used for the treatment of many chronic and severe conditions, including:
- 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.
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.