Explore answers to questions about biologics and biosimilars.

Before getting into biosimilars, it helps to know about medications called biologics. Biologics are large, complex molecules. Doctors use biologic medications to treat certain serious conditions.

A lot of medicines that you pick up at your local drugstore are made of fairly simple molecules. Medicines can generally be classified as small molecules or large molecules. Small molecules are made up of chemical structures and made with a chemical process. Biologics are large, complex molecules. Large molecules are bigger in size and made up of protein structures through living organisms such as bacteria and yeast.

A biosimilar is a biologic product that is highly similar to an existing reference product approved by the FDA, thus, the name biosimilar. The already approved biologic is known as the originator biologic product.

A biosimilar must show that it is highly similar to the originator biologic product in safety, purity, and potency (efficacy). A biosimilar must also demonstrate that it has no clinically meaningful differences in effectiveness and safety from the originator biologic product. A biosimilar generally has the same dosage as the originator biologic, and it’s taken the same way.

Some may view biosimilars as generic medicines because they are both similar versions of an original product. However, biosimilars are not like generic medicines because generic medicines are drugs made from chemical structures and biosimilars are made from living organisms.

Good question. Biosimilars offer doctors and patients more treatment options. Biosimilars may help create competitive pricing for biologics, potentially helping more people get access to biologic medicines.

Biosimilars are rigorously tested then they must be approved by the FDA. The FDA requires a biosimilar to be tested to demonstrate that it is similar to the original biologic in several ways:

• Biosimilars must be shown to have no clinically meaningful differences in safety, purity, and potency (efficacy) compared to the originator product.
• A biosimilar must show it’s designed to work in the body in the same way as the originator biologic product.
• A biosimilar is developed in a way that helps ensure that it is similar in function to the originator biologic product.