The European pharmaceutical industry welcomes the initiative by the European Commission Directorate General for the Internal Market, Industry, Entrepreneurship and SMEs (DG Grow) to host on 6 October 2015, an event on access to biosimilar medicines in Europe.
EuropaBio called on EU decision-makers to implement bold policies to ensure that the European healthcare biotech sector retains its competitiveness on a global scale and continues to deliver growth, jobs and innovation.
Attending a health conference organised by the European Commission in Brussels today, EuropaBio called on EU policy-makers to continue promoting biopharmaceutical innovation, while maintaining high EU standards for the safety and efficacy of medicines.
EFPIA, EUCOPE and EuropaBio are concerned that government initiated off-label use of medicines on economic grounds circumvents the robust EU authorisation process for medicinal products, which sets rigorous standards for market approval for specific medical needs based on the benefit to risk ratio.
Biopharmaceutical companies face high costs of clinical development for regulatory approval against a backdrop of increasingly fragmented reimbursement systems and assessment mechanisms unfit for the specificities of personalised therapies.