Generics and Biosimilars

2. Biosimilars

The European legislation defines a biosimilar as ‘a biological medicine that has been developed to be similar to an existing biological medicine’. A biosimilar mimics the effects of a previously approved biologic medicine and is intended to treat the same disease or diseases.

Once the protection for a product expires, e.g. patent or regulatory protection, the company no longer has exclusive rights to sell the medicine, and other companies can then manufacture and sell a copy of the medicine with the same active ingredient. These copies have been given the name ‘similar biological medicinal products’ or ‘biosimilars’. Biosimilars and original biologic medicines will differ in appearance, brand name and packaging, although the dose and how the medicines are given (by injection under the skin, into a muscle or directly into a vein) remain the same.