Labeling Standards for Biosimilar Products

Abstract

In 2010 Congress established a regulatory pathway for the approval of biosimilar products in the United States. FDA has embarked on developing the implementation framework for this pathway which includes creating guidance to assist biosimilar manufacturers in the development of these products. However, to date, the guidances have focused primarily on the technical standards that manufacturers should consider in order to successfully achieve product registration. As labeling is critical to the safe and effective use of medicinal products, as well as being essential to the content of subsequent promotional material, FDA should consider providing labeling standards that ensure that health care providers have the information needed to make informed decisions regarding the use of these important products.