Abstract
Biosimilars are not the same as generic drugs, although the intent behind them is the same (to lower costs and assure greater access to high-quality medicinal products). The scientific and quality aspects required to demonstrate similarity to a licensed reference therapeutic protein are complex requiring the undertaking of a comparability exercise with the intent to discover if there are any differences. A biosimilar should have the same biological and physiochemical characteristics and work by the same mechanism-of-action as a licensed reference product and be demonstrated to have the same safety and efficacy profile without clinically relevant differences. Biosimilars may not be licensed until the patent protection on the reference biological has expired.
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