This analysis provides a comprehensive, 75-item list of all likely protein and peptide targets based on reasonable selection criteria. This approach eliminates many products whose sales volume could never justify a biogeneric copy. It also eliminates products whose unique properties exclude them from the mainstream discussion of biogenerics. We hope that reviewing the characteristics of these plausible biogeneric targets will hasten their development and marketing.
BIOGENERIC TARGET PRODUCTS: THE REGULATORY PATHWAYSThe first step in assembling a list of potential biogeneric products is to examine the FDA definitions and regulatory pathways for drugs and biologicals. Many names have been proposed to describe such products, including biogenerics, biosimilars, generic biologics, and follow-on protein products. Definitions vary, but most convey similar concepts. For our purposes, FDA's definition of follow-on protein product will suffice: "a protein product which is intended to be a similar version or duplicate of an already approved or licensed protein product."1
New Drug Application and Biologics Licensing Application Pathways
The New Drug Application, or NDA pathway, was established in 1938 by the Food Drug and Cosmetic Act (FD&C Act).2 This pathway applies to products that are classified as drugs according to the FD&C Act definition:
"The term 'drug' means (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C)...."3