Biosimilars are a type of biologic medication that are safe and effective for treating many illnesses. The U.S. Food and Drug Administration has approved biosimilar medications to treat conditions such as chronic skin and bowel diseases, arthritis, kidney conditions, macular degeneration, and some cancers.
But what are biosimilar and interchangeable biologic medications? To answer that question, it helps to first know what biologic medications (biologics) are.
Biologics: Medications from Living Organisms
Biologics include medicines that generally come from living organisms, which can include animal cells and microorganisms, such as yeast and bacteria. That makes biologics different from conventional medications, which are commonly made from chemicals.
Biologics (including insulin) generally come from living organisms, so their nature varies, and their structures are generally more complex. Manufacturing biologics can be a more complicated process than making conventional drugs.
A biosimilar is a biologic that is highly similar to another biologic that is already FDA-approved (known as the original biologic). It is both normal and expected 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 their original biologic.
Biosimilars must have no clinically meaningful differences from their original biologic. On top of that, biosimilars must be:
- Given the same way (same route of administration).
- Have the same strength and dosage form.
- Have the same potential side effects.
This means that biosimilars provide the same treatment benefits and have the same risks as the original biologic.
Biosimilars Are Safe and Effective
Biosimilars are as safe and effective as the original biologic. Both are rigorously and thoroughly evaluated by the FDA before approval.
For biosimilars to be approved by the FDA, manufacturers must show that patients taking biosimilars do not have any new or worsening side effects as compared to people taking the original biologics.
As it does with all medication approvals, the FDA carefully reviews the data provided by manufacturers and takes several steps to ensure that all biosimilars meet standards for patient use. The FDA’s thorough evaluation makes sure that all biosimilar medications are as safe and effective as their original biologic and meet the FDA’s high standards for approval. This means you can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would from the original product.
In addition, the FDA closely regulates the manufacturing of biosimilars. The same quality manufacturing standards that apply to the original biologic also apply to the biosimilar. It must be manufactured in accordance with Current Good Manufacturing Practice requirements, which cover:
- Controls for the manufacturing, processing, packaging, or holding of a medication.
This helps to prevent manufacturing mistakes or unacceptable impurities, and to ensure consistent product quality.
Interchangeable Biosimilar Medications
An interchangeable biosimilar is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications.
An interchangeable biosimilar product may be substituted for the original product without consulting the prescriber, much like how generic drugs are routinely substituted for brand name drugs. This is commonly called pharmacy-level substitution and is subject to state pharmacy laws.
Both biosimilars and interchangeable biosimilars are as safe and effective as the original biologic they were compared to, and they can both be used in its place. This means that health care professionals can prescribe either a biosimilar or interchangeable biosimilar product instead of the original biologic.
Do Biosimilars Save Money?
Similar to generic drugs, biosimilars may cost less because manufacturers rely on the FDA’s finding that the original biologics are safe and effective. The lower cost is not a reflection of the effectiveness or safety of biosimilars. Because of the lower cost, biosimilars may be covered by more insurance companies and offer patients additional treatment options.
The 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. If you are covered by Medicare or Medicaid, check with the Centers for Medicare & Medicaid Services and your plan provider.
Biologics are among the fastest growing, and most expensive, segments of the prescription medication market. The FDA approval of additional biosimilar and interchangeable biosimilar medications may help stimulate competition, which would give patients more treatment options and potentially less expensive alternatives.
You can search the Purple Book database for information about biological products, including biosimilar and interchangeable biosimilar products, approved by the FDA.