Biosimilars 101

The biologics market could see some significant changes with the current and upcoming interchangeability approvals of several biosimilar products. Let's dive into what biosimilars are and the importance of interchangeability.

What is a biosimilar?

A biosimilar is a potential alternative for an existing FDA-approved biologic. They are highly similar (can have minor differences in inactive components) to and have no clinically meaningful differences from an existing FDA-approved biologic reference product. Biosimilars are typically used to treat chronic health conditions (neutropenia, autoimmune inflammatory conditions, diabetes, and certain types of cancer).

Are they generics?

No. Unlike generic drugs, biosimilar drugs are not identical to the originator biologic. Each biosimilar product will vary slightly from the reference product as will each lot from a reference product due to variation in living organisms. Therefore many biologics are not interchangeable with the originator biologic, which can impact prescribing and ultimately costs.

Why is interchangeability important?

Interchangeability designation creates more choice for prescribers and patients — which could heat up the market and reduce costs. To gain interchangeability status the manufacturer must:

• Show that the biosimilar product will produce the same clinical result as the originator biologic in any given patient.
• Provide data that displays information to evaluate any risks and examine safety and efficacy when switching between the biosimilar and originator biologic product.