Biosimilars: Fundamentals and authorization as per U.S. perspective

Abstract

Biosimilars are biological products that are the replicas of their innovator biopharmaceuticals. At the moment, biological products account for 10 -15% of the total pharmaceutical market. More than one-fifth of new medicines launched on the world market each year are now biotechnology derived. These are developed after patent expiration of innovator biopharmaceuticals and are submitted for separate marketing approval. In view of the structural and manufacturing complexities of biopharmaceuticals, biosimilars should not be considered as biological generics. Each class of biologic varies in its benefit and risk profile, the nature and frequency of adverse events, the breadth of clinical indications and whether surrogate markers for efficacy are available and validated. But most of the countries do not have specific guidelines for potential market of biological products. Following the legislation that allowed the FDA to approve biosimilars in the United States, biological products that are similar to the reference product in terms of safety, purity and potency are gradually entering into the market. To date, only five biosimilars have been approved in the U. S. although many agents are currently undergoing trials and may soon become available. This article will address the differences between biosimilars and generics, issues concern with the approval process, use of biosimilars and need.