A biosimilar is a new biological product that has been developed to be similar to an existing (reference) licensed biological product in terms of quality, safety and efficacy. Biosimilars cannot be proven to be identical to their reference products. They present new challenges that are not ordinarily presented by small-molecule generic medicines.
Differences in starting materials, manufacturing processes and physical characteristics (e.g. degree of glycosylation) mean that biosimilars may have different clinical characteristics from an originator product, such that additional testing, possibly including clinical studies, is required before a marketing authorisation can be granted.
This is reflected in the pharmaceutical legislation for biosimilars which takes the approach that these products are not generics and must therefore be treated differently. Since 2003, an EU pathway for approving biosimilar medicines has been in place. The main part of the evaluation is a comparison of the biosimilar with its reference medicine to show that there are no significant differences between them.
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