Biologics and Biosimilars

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Biologics are medicines made from living cells through highly complex manufacturing processes. A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDA‐approved biologic product. Biologics, on the other hand, are much more complex molecules (in fact, they are proteins) created through biological processes in living cells. Indeed, the demand for biologics is growing exponentially due to their ability to bind to specific cells, which means they have fewer side effects than broadly acting drugs. The chemicals traditionally used in cancer therapy, for instance, bind to every fast-dividing cell because this is a hallmark of cancer cells, but this results in observed side effects such as hair loss. Biologics are better at targeting cancerous cells.

  • Biologics as protein therapies
  • Biosimilar labeling
  • Analytical characterization

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