Regulatory overview of biosimilars in Europe
A biosimilar is a biological medicine similar, but not identical, to an already registered reference bio therapeutic product in terms of quality, safety, and efficacy. These drugs are also called as biosimilar products‘, follow-on protein products’ and subsequent-entry biologics‘. The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally. Since the EU approved the first biosimilar in 2006, healthcare professionals have gained increasing experience with their use. Today, biosimilars are an integral part of the effective biological therapies available in the EU, supported by adequate safeguards protecting patient safety. In Europe, in 2001, legislation concerning biosimilar was codified as Directive 2001/83/EC to create a new marketing authorization procedure for similar biological medicinal products and also Committee for Medicinal Products for Human Use (CHMP) of the EMA is concern with these biosimilar products. The aim of biosimilars development is to demonstrate bio similarity - high similarity in terms of structure, biological activity and efficacy, safety and immunogenicity profile. Safety of biosimilars is monitored through pharmacovigilance activities, in the same way as for any other medicine. Biosimilars can offer advantages to EU healthcare systems, as it is expected to improve patients’ access to safe and effective biological medicines with proven quality.
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