Perspective: Demystifying CMC Regulatory Strategy for Biologics, Part 2: Biologics Are Not Chemical Drugs

Posted 01 November 2011 | By John Geigert, PhD, RAC 

Senior managers, especially if they have recently moved from the chemical drug side of the business into biologics, may raise the question of whether biologics are really different from chemical drugs or if this is just a perception. As clearly stated by the regulatory authorities, biologics are not chemical drugs and similar biologics are not biogenerics.

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