Other than the obvious difference of size, the main difference between these two therapeutic modalities is that while small molecule drugs are chemically derived, biologics are extracted from living organisms. Most drugs on the market today will be small molecule compounds manufactured through chemical synthesis.
Biologics regulated by CBER include: cellular products, gene therapy, vaccines, allergenic extracts, antitoxins, antivenins, venoms, blood, blood components, and plasma derived products.
Other than the obvious difference of size, the main difference...
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