EMA has published scientific guidelines to help developers of biosimilar medicines conform to the strict regulatory requirements for approving biosimilars and to provide transparency on the requirements for approving biosimilars.

Applicants preparing to request marketing authorisation for a biosimilar medicine via EMA should follow the Agency's procedural advice for the centralised authorisation of biosimilar medicines.

The safety of biosimilars is monitored through pharmacovigilance activities once they are on the market, in the same way as for other medicines.

A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilars in the European Union (EU).

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

The EU approved the first biosimilar in 2006.

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.

The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally.

The evidence acquired over ten years of clinical experience shows that biosimilars approved through EMA can be used as safely and effectively in all their approved indications as other biological medicines.

Source: www.ema.europa.eu