Saturday, 3 January 2015

Guideline on similar biological medicinal products

European Commission have issued a final guideline comes into effect 30 April 2015 although applicants may make use of it prior to that date.

The guideline outlines the general principles to be applied for similar biological medicinal products (biosimilars) as referred to in Directive 2001/83/EC, 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.

For details see: biosimilars

Posted by Tim Sandle