EGA President, Mr Didier Barret, welcomed the EU biosimilars’ framework and reminded the audience that biosimilar medicines have been safely in use for five years.

While EGA Director General, Mr Greg Perry, pointed out the additional EU regulatory and industrial policy measures which are needed to capitalise on the EU advanced framework. He commented that ‘the regulatory framework should be adapted to allow and accept global development programmes for biosimilars in order to ensure the availability and affordability of this important category of medicines’.

This issue has been echoed by other authors who have warned of the cost of region-specific biosimilar regulations, which demand separate development programmes [1].

Other issues high on Mr Perry’s important list were increased promotion of EU high standards beyond its borders and measures to encourage development and manufacturing in Europe.

Mr Perry also welcomed and supported the DG Enterprise project group on market access and uptake of biosimilars, through its platform on access to medicines in Europe. The objective of this project is to define what the necessary conditions within the pharmaceutical environment are to ensure informed, adequate uptake of biosimilars.

‘For the sake of Europe’s patients’, Mr Perry concluded, ‘we need incentives for the demand-side, a consistent rational approach towards interchangeability, acceptance of different cost-price structures than for generic medicines, and an increase of awareness and information aiming at reinforcing the confidence of patients and healthcare professionals in these high quality biopharmaceuticals’.

Reference

1. GaBI Online - Generics and Biosimilars Initiative. Need for a global pathway for biosimilars. [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International. Available from: www.gabionline.net/Biosimilars/Research/Need-for-a-global-pathway-for-biosimilars