The Heterogeneity of Biologics

Jim M. Koeller, MS FHOPA, professor of pharmacotherapy and Eli Lilly/CRSublett Fellow in the College of Pharmacy, The University of Texas at Austin, and clinical professor of medicine and oncology, University of Texas Health Science Center, discusses the heterogeneity of biologics.

Biosimilars are subject to an elaborate approval process. Drug developers have to show that the biosimilar is highly similar to the originator biologic. However, some people remain skeptical of biosimilars because they’re not identical to the originator drug.

It’s important to recognize that even biologics are heterogenous, explains Koeller. Biologics have been on the market for over 35 years. Yet, there lacks a general knowledge about the manufacturing process of these agents. Ultimately, a deeper understanding of the development of biologics and biosimilars is needed, concludes Koeller.