Charles E. DiLiberti
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Developing biogeneric products is a hot topic, and the subject of many recent technical publications. Unfortunately, the lack
of a comprehensive and definitive list of target products for biogeneric manufacturers has fostered ambiguity in many of the
public discussions. Sorting through all the protein products that have been approved or licensed is an unwieldy and confusing
task.
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 PATHWAYS
The 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
Innovative protein products can be brought to the US marketplace via any of four possible regulatory pathways. The pathway
that the target product employs impacts the pathway that the biogeneric product uses. The four pathways are reviewed as a
first step in establishing reasonable criteria to limit the final list of biogeneric targets.
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
