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BIOSIMILARS

Chemical Medicine: "Refers to medicines that are manufactured without the involvement of living organisms."

Unlike generic chemical medicines where the active ingredients are identical, biosimilars are not identical to the originator biologic. They are similar, but not the same. Biosimilars made by different manufacturers differ from the original product and from each other. Due to the complex structure of biologic medicines and the processes involved in production, biosimilars must be shown on the basis of analytical, non-clinical and clinical data to be similar to an original biologic in terms of structural characteristics, and safety and efficacy. Minor differences with the active ingredient are expected and permitted so long as any such differences are demonstrated not to be clinically meaningful.i The patents of a growing number of biologic medicines have already expired or are due to expire, which has led to an increased interest in the development of biosimilars.ii

Health Canada Definition of Biosimilars

The Health Canada definition of a biosimilar is as follows:

A Subsequent Entry Biologic (also referred to as biosimilar) is a biologic drug that enters the market subsequent to a version previously authorized in Canada, and with demonstrated similarity to a reference biologic drug.iii

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