The establishment of recombinant DNA technologies in the past several decades has made it possible to develop a wide variety of therapeutic proteins to address a corresponding variety of unmet medical needs. Therapeutic proteins have had a major impact on health care, and are likely to grow in importance in the future. As the field of biotherapeutics evolves, there are many current and future challenges to be met. A highly competitive environment has emerged, in many cases with multiple products designed to modulate the same therapeutic target or pathway. The competition is resulting in more effective therapeutics as the need to differentiate among similar products becomes crucial. The costs and timelines for development of therapeutic proteins are increasing dramatically, leading to the tendency to focus primarily on those molecules with the greatest chance for success in late-stage clinical programs. As the field of therapeutic proteins continues to mature, the challenge of follow-on biologics needs to be addressed with the establishment of regulatory guidelines appropriate for the complexity of biotherapeutics.
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