British Journal of Clinical Pharmacology (04/11/15) de Mora, Fernand

Under a framework developed by the European Medicines Agency (EMA), a biosimilar is a regulatory term that refers to evidence-based studies required to prove that a high-quality biological medicine is equivalent to an original products. While they are not innovative products, the EMA's pathway for their approval represented a new approach that spurred confusion in some healthcare professionals about the scientific evidence behind their authorization. In an effort to clarify some of the confusion, this paper explains what a biosimilar is not, and why. Author Fernando de Mora, from the Therapeutics and Toxicology Universitat Autònoma de Barcelona, explains that a biosimilar is not a generic drug, an original product, a biobetter, or a "stand-alone." As a result, he writes, biosimilars "should not be managed as such therapeutically, commercially, or from a healthcare policy viewpoint." By increasing awareness of what a biosimilar is—and what it is not—de Mora hopes to increase healthcare professionals' trust of biosimilars, which should benefit patients in the end.

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