Biologic (Biological Product)
A pharmaceutical product derived from biological sources or produced using biological processes, including proteins, peptides, monoclonal antibodies, and vaccines. Biologics are typically regulated differently from chemically synthesised small molecule drugs and follow the BLA pathway in the US.
Technical Context
Biological products are distinguished from conventional drugs by: molecular complexity (large, heterogeneous molecules that cannot be fully characterised by physicochemical methods alone), sensitivity to manufacturing conditions (the product is defined partly by its manufacturing process — 'the process is the product'), and biological source (produced by living systems). The Biologics Price Competition and Innovation Act (BPCIA, 2010) created the US biosimilar pathway (351(k)). Products transitioned from NDA to BLA regulation: insulin, growth hormone, and other protein products were reclassified as biologics under the BPCIA 'deemed to be a license' provision (effective March 2020). This transition affects market exclusivity provisions, patent challenge procedures, and generic/biosimilar pathways. The distinction between small molecule peptides (NDA) and biological peptides (BLA) is based on molecular complexity and manufacturing method rather than a strict size cutoff.