BEBAC  Ing. Helmut Schütz


Guideline on similar biological medicinal products

On 29 Oct 2014 EMA’s Committee for Medicinal Products for Human Use (CHMP) published the final guideline (dated 23 October 2013).

This Guideline outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Directive 2001/83/EC, as amended, where it is stated that ‘the general principles to be applied [for similar biological medicinal products] are addressed in a guideline taking into account the characteristics of the con­cerned biological medicinal product published by the Agency’.

This Guideline describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles for establishing biosimilarity.

The guideline will come into effect on 30 April 2015, although applicants may apply some or all provisions of this guideline in advance of this date.