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Previous Volume 358:843-849 February 21, 2008 Number 8 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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Since recombinant human insulin (Humulin) became the first recombinant-protein drug approved by the Food and Drug Administration (FDA) 25 years ago, nearly 100 recombinant-protein therapeutics, including other hormones and monoclonal antibodies, have become part of clinical practice (Table 1).¹ Though small-molecule drugs are more common than recombinant-protein drugs — only 1 of the top 200 prescribed drugs of 2006 (on the basis of prescription volume) was a recombinant protein — protein-based therapeutics have been used to treat diabetes and anemia, as well as relatively rarer conditions, such as rheumatoid arthritis, Gaucher's disease, and multiple sclerosis.^2,3

View this table:   Table 1. Classes of Approved . . . [Full Text of this Article]

 
Historical Distinction between "Biologics" and "Drugs"

Past Experience with Follow-on Proteins

New Mechanisms for Approving Follow-on Protein Products

Conclusions

Source Information

From the Department of Medicine, Massachusetts General Hospital (D.M.D.); and the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital (A.S.K.) — both in Boston.

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