Biosimilars & Public Procurement

A Biosimilar is a biologic medicine containing a version of the active substance of an already authorised biologic medicine, which has shown similarity to the original medicine. As no two biologic medicines are the same, EuropaBio has often advocated for a high standard of clinical evidence before issuing any new medicine to a patient.

The EuropaBio Biosimilars Working Group has, therefore, worked on topics around clinical evidence standards for biosimilars, traceability of the original products versus the biosimilar, as well as regulatory convergence at a global level. The WG also develops thought leadership pieces in the policy landscape, for example on new topics, such as biosimilars in new indications, in new patient populations, for rare diseases, or for cell and gene therapies.

Furthermore, the WG has also looked at the topic of public procurement as a means of improving patient access to innovative medicines within the European Union.
The WG has published papers on efficient methods of public procurement of pharmaceutical products, and is currently working on revised position papers, within the context of the EU Pharmaceutical Strategy, to assist policymakers in identifying ways of encouraging sustainable and efficient access pathways for biologics within the European Union.