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, The University of Texas Health Science Center, discusses the inherent variability of recombinant DNA technology behind biosimilars.

Variability from post-translational modifications during replication can take place when making any biologic, says Koeller.

Also, variability when formulating a product can exist because biologics are not made through chemical synthesis like aspirin, Koeller continues. Instead, a monoclonal antibody in a solution is filtered repeatedly. 

Though filtering removes larger impurities, small protein fragments and glycans can exist in the final product. From there, separation chromatography isolates the protein.

These batch differences may become biosimilars that are approved based on comparability standards set by the FDA, says Koeller. 

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Jim M. Koeller, MS, FHOPA, discusses the inherent variability of recombinant DNA technology behind biosimilars. 
 

Explaining the Variability of Biologics and Biosimilars

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.

Jim M. Koeller, MS FHOPA, discusses the heterogeneity of biologics. 
 

Jim M. Koeller, MS FHOPA

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Explaining the Variability of Biologics and Biosimilars

The Heterogeneity of Biologics