Philip E Johnson1. 1. H. Lee Moffitt Cancer Center, 12902 Magnolia Dr., Tampa, FL 33612-9497, USA. johnsonp@moffitt.usf.edu
Abstract
PURPOSE: Historical perspective on the use of biotechnology for drug product development, terminology used for biotechnology drug products, potential benefits of biotechnology, applications of biotechnology to drug product development, pharmacy considerations in the use of biopharmaceuticals, and the classification of biotechnology products by the Food and Drug Administration (FDA) are discussed. SUMMARY: Applications of biotechnology to medicine have a long history, and the pace of new applications has accelerated in recent decades. Various terms, including biosimilars, follow-on biologics, and follow-on proteins, have been used to refer to biotechnology products that are highly similar to the reference product, notwithstanding minor differences. New approaches to the production of drug products have been made feasible through biotechnology, facilitating the prevention, cure, and treatment of diseases. Recombinant DNA technology, monoclonal antibodies, and gene therapy are among the applications of biotechnology processes to drug development. Storage, handling, preparation, and administration are among the pharmacy considerations in the use of biopharmaceuticals. The FDA has not defined or developed a pathway for establishing therapeutic equivalence of biosimilar and innovator products. Payers may attempt to make decisions about therapeutic equivalence in order to reduce costs. CONCLUSION: Considerable confusion surrounds biosimilars. Pharmacists can help resolve the confusion by explaining to lawmakers and health-system decision-makers the terminology and science of biotechnology processes and the implications for use of biotechnology products in the future.
PURPOSE: Historical perspective on the use of biotechnology for drug product development, terminology used for biotechnology drug products, potential benefits of biotechnology, applications of biotechnology to drug product development, pharmacy considerations in the use of biopharmaceuticals, and the classification of biotechnology products by the Food and Drug Administration (FDA) are discussed. SUMMARY: Applications of biotechnology to medicine have a long history, and the pace of new applications has accelerated in recent decades. Various terms, including biosimilars, follow-on biologics, and follow-on proteins, have been used to refer to biotechnology products that are highly similar to the reference product, notwithstanding minor differences. New approaches to the production of drug products have been made feasible through biotechnology, facilitating the prevention, cure, and treatment of diseases. Recombinant DNA technology, monoclonal antibodies, and gene therapy are among the applications of biotechnology processes to drug development. Storage, handling, preparation, and administration are among the pharmacy considerations in the use of biopharmaceuticals. The FDA has not defined or developed a pathway for establishing therapeutic equivalence of biosimilar and innovator products. Payers may attempt to make decisions about therapeutic equivalence in order to reduce costs. CONCLUSION: Considerable confusion surrounds biosimilars. Pharmacists can help resolve the confusion by explaining to lawmakers and health-system decision-makers the terminology and science of biotechnology processes and the implications for use of biotechnology products in the future.