The rise of biosimilars: How they got here and where they are going.

Biosimilars have become a subject of great interest in the past few years. The European Union and the United States are seeing an increasing number of biosimilar applications and approvals. The development of a biosimilar is significantly more complex and costly than a small molecule generic product. In the European Union, there has been a wider use of these medications compared to the United States. More biosimilars are gaining approval in the United States, and these products will likely alter the healthcare system in highly impactful ways. Understanding the regulatory process, the risks, and benefits will enable clinicians to be prepared and maximize the utility of these medications when they enter the market. This article introduces the concept of a biosimilar, discusses the regulatory process in the United States, and reviews the risks and benefits of these products.