Subscribe: FDA Consumer Health Information
Biosimilar products provide more treatment options to patients, potentially lowering treatment costs and increasing access to lifesaving medications.
The U.S. Food and Drug Administration has approved biosimilar products to treat conditions such as cancer, Crohn’s disease and colitis, irritable bowel syndrome, rheumatoid arthritis, psoriasis and more.
But what are biosimilars? To answer this question, it helps to first know what biological products (biologics) are.
Biolosimilars: Medications From Living Organisms
Biologics are medicines that generally come from living organisms, which can include humans, animals and microorganisms, such as yeast and bacteria.
That makes biologics different from conventional medications, which are generally made from chemicals, or are chemically synthesized. Generally, it is relatively easy to define the structure of a conventional medicine.
Unlike conventional medications, biologics can’t be made by following a chemical “recipe.” Because biologics come from living organisms, they are variable in nature and their structures are generally more complex and not as easy to define and characterize. In turn, developing biologics generally is a far more difficult process than manufacturing conventional drugs.
A biosimilar is a biologic that is highly similar to another biologic that’s already approved by the FDA (known as the reference product). A biosimilar is not like a generic drug. It’s not the exact duplicate of the reference product. Biosimilars have allowable differences. Any differences between the proposed biosimilar product and reference product are carefully evaluated by the FDA to ensure the biosimilar meets the FDA’s high approval standards.
Biosimilars Are Safe and Effective
The FDA rigorously and thoroughly evaluates a biologic’s safety and effectiveness before granting it approval.
Because the structure of a biologic and the process used to make it are typically complex, developing a biosimilar generally is not as easy as producing a generic drug, which is a copy of a brand name, conventional drug.
Before approving a biosimilar, FDA experts must conclude, among other things, that there are no clinically meaningful differences between the biosimilar and its reference product—the already approved biologic—in terms of safety, purity and potency. This thorough evaluation helps to ensure that all biosimilar products are safe and effective and meet the Agency’s high standards for approval.
A biosimilar must have the same strength, dosage form, and route of administration (injection in the arm, for example) as the reference product. It also must be manufactured following Current Good Manufacturing Practices, which covers manufacturing, facilities and controls for the manufacturing, processing, packaging or holding of a drug product. This helps to prevent manufacturing mistakes or unacceptable impurities and ensures product quality.
Patients can rest assured that they’ll be able to rely upon the safety and effectiveness of an FDA-approved biosimilar, just as they can rely on the safety and effectiveness of the reference product that the biosimilar was compared to.
Like other biologics, biosimilars generally must be prescribed by a doctor.
Biologics are among the fastest growing segments of the prescription product market. The FDA approval of additional biosimilars will help stimulate competition. Patients will have more treatment options and potentially less expensive alternatives to approved products.
This article appears on the FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
Updated: October 23, 2017
back to top
Get Consumer Updates via e-mail