Ethel Zimmerman Wiener Professor of Public Policy, HKS; Henry and Allison McCance Professor of Business Administration, HBS
Drs Frankel and McKay first note that the FDA is able to ensure biosimilar and reference biologic quality through prerelease specifications. But these specifications cover only a subset of all measurable quality attributes. If FDA testing were adequate to predict all emergent quality-related safety issues with biologics, then there never would have been cases of pure red blood cell aplasia associated with Eprex1 or HX575, which are biosimilar versions of epoetin-a, nor would have there have been deaths due to contaminated heparin in the United States in 2008.
Chandra, Amitabh, and Jacqueline Vanderpuye-Orgle. "Competition and Biosimilar Products--In Reply." JAMA: Journal of the American Medical Association 314.24 (December 2015): 2692-2692.