Biologic drugs are highly complex molecules, which have added tremendous value to modern medicine. Although these drugs may be associated with adverse events, the risks of use are dramatically outweighed by the benefits achieved. In 2013, biologicals comprised an annual global market of US$170 billion, with recombinant insulin, human growth hormone, erythropoietins, and various monoclonal antibodies (mAbs) among the leading categories of products.1 The biopharmaceutical market is predicted to grow at greater than 20% annually as a result of a promising pipeline, approval for more common conditions, increased utilization, and expanded indications.2,3
Biologic drugs are structurally complex and may have several functional domains within a single molecule. For example, individual mAbs present a unique profile with respect to the characteristics of the antigen-binding region, the Fc cytotoxic effector function, and binding to Fc receptors.4 Since the introduction of biologic drugs, more sophisticated assays have been developed that allow for greater in-depth characterization of complex proteins, both on a physicochemical and a functional level. These modern assays permit greater precision for biologic drug development regarding potency and purity.4
Despite their enormous value for our health care system, biopharmaceuticals have become a serious threat to the system itself. Some of the treatments now available are extraordinarily expensive, costing over US$600,000 and more per patient.5 Because of the high cost many patients who qualify for treatment with a biologic drug may be left untreated. Costs may be warranted if the medicine is new and innovative; however, an innovation is finite, and it is no longer an innovation when its patent protection expires.
It is estimated that US$67 billion worth of patents on biologic agents will expire before 2020 (Table 1).6 With the expiry of patents and the development of these new assays, the door has been opened for the development of biosimilar versions of originator agents.
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