Journal of the American Medical Association (07/21/15) Vol. 314, No. 3, P. 225; Chandra, Amitabh; Vanderpuye-Orgle, Jacqueline

Although new developments suggest that biosimilars could become the equivalent of generic drugs, Amitabh Chandra of Harvard University and Jacqueline Vanderpuye-Orgle of Precision Health Economics argue that biosimilars are unlikely to deliver such benefits. Biologics are manufactured using complex living systems and cannot be copied identically, so they are not automatically interchangeable with the reference product. The costly manufacturing process with biologics means that cost savings will be smaller than with generics. High production costs will limit market entry and competition. Biosimilars, therefore, could have less effect on the marketplace than generic products do for branded small-molecule drugs. Because biosimilarity does not necessarily mean interchangeability, prescribing physicians must have first-hand experience with biosimilars to be comfortable substituting a biosimilar for a biologic. Traceability and specific naming and labeling could increase confidence in biosimilars, although experts are divided on how this should be done. Postmarket surveillance could reduce uncertainty about biosimilars, encouraging their use and expanding uptake. This would provide better financial relief to patients who switch to biosimilars, and increase the incentives for more efficient manufacturing processes and competition, the authors conclude.

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