Frequently Asked Questions
-
A biosimilar is a biologic that is highly similar to, and has no clinically meaningful differences from another biologic that is already approved by the FDA (known as the reference product)
-
The FDA has implemented a policy that requires distinguishable suffixes as part of the non-proprietary name of biologic (biosimilar) medicines. For the reference product, the FDA recommends the use of a “core name” that is designated by the United States Pharmacopeial Convention with a 4-letter suffix. For a biosimilar product, the core name will be the same as the reference product but with a different f-letter suffix. This is useful to track adverse events, facilitate the appropriate targeting of any actions against a specific product vs. the enter class of products, minimize the risk of inadvertent substitution, and promote the accurate identification of a product to pharmacists and other healthcare provider.
-
Comparative clinical studies and testing are needed to demonstrate that there is no clinical meaningful differences in terms of safety and efficacy between a biosimilar and the reference product.
-
While not common, biosimilars can be approved for fewer indications than the reference product. This may sometimes occur if the reference product has patent exclusivity for an indication or protected by some other reason related to an indication (such as orphan drug designation or a different mechanism of action)