Current and future considerations for the new classes of biologicals

Key structural features of biologicals and their development are explained, and the fundamental distinctions between biological and chemical drugs in terms of their discovery, scale-up from research to commercial quantities, quality control, regulatory requirements, and potential for generic substitution are discussed.

Recent advances in biotechnology have accelerated the introduction of biological protein drugs into the marketplace, offering new treatment options and challenges for pharmacists. Because these drugs are produced in living systems and are structurally complex, they are more difficult to manufacture, purify, and evaluate than are traditional chemical drugs. The production of recombinant-DNA-based protein and monoclonal antibody drugs is explained, and the strengths and limitations in selecting one or another host system (i.e., bacteria, yeast, or mammalian cells) for making a given biological drug are explored. Subtle variations in production methods can lead to significant differences in product volume, potential viral or bacterial contamination, bioactivity, and toxicity. Like manufacturers, federal regulators face difficult new challenges because of the structural complexity and in vivo synthesis of biologicals. Pharmacists and regulators alike must determine when and if therapeutic interchange is relevant to biologicals. Because biologicals are so difficult to manufacture and test, noninnovator biologicals must be subject to more oversight than traditional generic drugs.

Biologicals are complex agents whose production and properties present many considerations that are not associated with traditional chemical drugs.