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Pharmacist Substitution of Biological Products: Issues and Considerations
Journal of Managed Care & Specialty Pharmacy (07/01/15) Vol. 21, No. 7, P. 532; Li, E.; Ramanan, S.; Green, L.
In a commentary, researchers from the University of New England College of Pharmacy discuss issues and considerations for pharmacist substitution of biological products. The authors review the differences between generics and biosimilars, describe their regulatory approval pathways, discuss interchangeability and substitution, and review substitution of interchangeable biosimilars. In particular, they highlight important professional considerations for pharmacists. Biosimilars are not identical to their reference products, as each manufacturer uses unique cell lines and processes, and clinical studies establishing biosimilarity are needed prior to approval. The researchers point out that although the Food and Drug Administration has not yet released final guidelines on interchangeable biosimilars, more stringent standards of similarity will be required in order to obtain a designation as interchangeable.
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