The Challenge

The increasing use of biological therapies has brought considerable benefits to patients, but has also been a driver of costs to healthcare systems. However, there are now a number of biosimilar therapies and off-patent biologics available, offering the opportunity for substantial savings over the originator product.

Despite this potential, there has been little sign of a market to incentivise uptake of these products. This was in part due a lack of guidance for policymakers on how to create a fair, competitive and sustainable market for off-patent biologicals and biosimilars in Europe.

The FIPRA Approach

FIPRA worked with a range of stakeholders including national authorities, clinicians, and patients bringing perspectives from different parts of Europe, as well as manufacturers of biologics and biosimilars.

Following an in-depth assessment on the learnings from different policy approaches, analysing the intended and unintended consequences, the group contributed to a report entitled “How to realise the potential of off-patent biologics and biosimilars in Europe”. This set out the importance of a multi-stakeholder approach along with a clear set of policy recommendations for demand-side and supply-side incentives.

The Outcome

The recommendations were presented with policymakers and payers at a meeting of experts convened by the European Commission on best practice on procurement policies to ensure a stable and competitive market. The report was subsequently published in the Generics and Biosimilars Initiative (GaBi) Journal.