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The second class of drugs created by biotechnology is called (also referred to as New Biological Entities or NBEs.) In contrast to small molecule drugs that are chemically synthesized, most biologics are proteins, nucleic acids or cells and tissues. Biologics can be made from human, animal, or microorganisms – or produced by recombinant DNA technology. Examples of biologics include: vaccines, cell or , therapeutic protein hormones, , tissue growth factors, and.

The problem is that the probability that a small molecule drug gets through clinical trials is unchanged after 50 years. In spite of the substantial scientific advances and increased investment, over the last 20 years the FDA has approved an average of a year. (To be fair, this is indication-dependent. For example, in oncology, things have gotten significantly better. In most other areas, particularly and metabolism, they have not.)

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  • Unfortunately most diseases don’t work that simply. There are a few diseases that do, (i.e. insulin and diabetes, Gleevec –Philadelphia Chromosome and chronic myeloid leukemia), but most small molecule drugs rarely act on a single target (target-based therapy in oncology being the bright spot.)
  • Biologics vs. Small Molecule Drugs

    The bio/pharmaceutical industry embraces the discovery and development of small molecule drugs and peptides (both referred to as New Chemical Entities or NCEs) and drugs, also called biologics (also referred to as New Biological Entities or NBEs). Small Molecule, peptide and drugs can take on different names over the lifetime of drug discovery and development and marketing, as shown in Fig 1 and described in Ref 5.

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