How to realise the potential of off-patent biologics and biosimilars in Europe? Guidance to policy makers TBD

Category: Perspective
Author(s): , , , , , , , , , ,
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Keywords: biologics, biosimilars, competition, Europe, policy, sustainability

Objectives: This document aims to provide guidance to policy makers with a view to fostering a fair, competitive and sustainable market for off-patent biologics and biosimilars in Europe.
Methods: Individuals and stakeholder representatives from patient groups, clinicians, healthcare professional organisations, government bodies, and industry participated in a series of roundtable discussions.
Results: Policy makers need to involve physicians and other stakeholders in designing smart procurement and reimbursement mechanisms that incite competition in the market for off-patent biologics and biosimilars, and that guarantee the availability of choice between products. With respect to the demand-side, the clinical profession, academia and patients need to be involved in developing a prescribing and switching framework for off-patent biologics and biosimilars. The physician prescribes an off-patent biologic or biosimilar, or switches between products based on clinical judgement and high-quality evidence. In this respect, hospital pharmacists provide a ‘hub of information’ about the uptake, real-world use and evidence base on off-patent biologics and biosimilars. Other demand-side incentives, such as physician quotas, should not be introduced without examining the impact together with relevant stakeholders including medical professionals, patients and regulators in order to meet different policy goals. Pharmacist substitution should only be considered in well-defined circumstances, motivated by specific needs.
Conclusions: Policy makers need to introduce a long-term, multi-stakeholder, specific policy framework for off-patent biologics and biosimilars.

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