Published: 21 June 2016
Author(s): Luca Pasina, Gianluigi Casadei, Alessandro Nobili
Issue: June 2016
Section: Reflections in Internal Medicine

Biologics embrace a wide range of substances synthesized by cells or living organisms by means of different biological processes, including recombinant DNA technology, controlled gene expression, or antibody technologies. A biosimilar establishes similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exercise. Minimizing development costs and accelerating their market access create a convergence of interests between health services, worried about sustainability, and generic manufacturers.

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