7. Types of Marketing Authorisation Applications

A biosimilar is a biological medicine highly similar to another biological medicine already approved in the EU, the reference medicine. Similarity refers to structure, biological activity and efficacy, safety and immunogenicity profile (the intrinsic ability of proteins and other biological medicines to cause an immune response).

A biosimilar is not regarded as a generic of a biological medicine. This is mostly because the natural variability and more complex manufacturing of biological medicines do not allow an exact replication of the molecular micro-heterogeneity. In this way they are not identical. Consequently, more studies are required for regulatory approval of biosimilars than for generics. Comprehensive comparability studies are needed to generate evidence substantiating the similar nature, in terms of quality, safety and efficacy (absence of clinically meaningful differences), of the similar biological medicine and the chosen reference medicinal product.

Legislation states: Where a biological medicine which is similar to a reference biological product does not meet the conditions of a generic product, the results of appropriate non-clinical tests or clinical trials must be provided. This applies in particular to differences relating to:

• raw materials (e.g., difficulty to characterise, such as biological substances arising from extraction from biological sources).
• manufacturing processes.

The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Section 4, Part II, Annex I to Directive 2001/83/EC and the related detailed guidelines. Due to the diversity of biological medicines the need for additional non-clinical tests and clinical studies will be identified by the competent authorities. The chosen reference medicine must be a medicine authorised in the Union, on the basis of a complete dossier in accordance with Article 8 of Directive 2001/83/EC.

Legal basis: Article 10 (4) of Directive 2001/83 (EC); Annex I, Part II section 4 of Directive 2001/83/EC