Biosimilars: The Need, The Challenge, The Future

The FDA Perspective

Michael S. Epstein MD, FACG, AGAF; Eli D. Ehrenpreis, MD; Prasad M. Kulkarni MD, FACG


Am J Gastroenterol. 2014;109(12):1856-1859. 

In This Article


Agents that have biologically similar properties to FDA-approved biologics are termed "biosimilars". Unlike the fabrication of generic drugs, the manufacturing of proteins derived by DNA recombinant technology to mimic the effects of currently marketed biologics does not result in the production of an identical product.[6] Because of the complexity of molecular structures and manufacturing processes, biosimilars may have unique structures compared with the products that their activities resemble.

Biosimilar development represents a large profit potential for pharmaceutical manufacturers. Consumers and policy makers view appropriate market introduction of biosimilars as high priority because of the prospect of reduced medical costs. A number of biologics with very high annual sales will lose patent protection in the next few years. These include Rituxan (rituximab, an anti-inflammatory and chemotherapeutic agent), Enbrel (etanercept, used for rheumatoid arthritis), and Remicade (infliximab). Production and sales of biosimilars is estimated to reach $20 billion in annual business by 2020.[7]