Overview

Key messages:

Biosimilar medicines are off-patent “follow-on” versions of biological medicines made or derived from a biological source (living cells or organisms) that use the same active substance.

• Biosimilars provide the same effectiveness and safety as the originator medicine.
• Biosimilars are supplied at lower prices and can also reduce the prices of originator products (by competing with them), decrease spending and improve access to biological medicines.
• Designing or updating policy, addressing implementation, and monitoring are all key to realizing the potential of biosimilar medicines. This puts the onus on policy-makers to take appropriate measures to:
  • Set the price of biosimilars – considering the prices of other biosimilars and biological originators in their country (price link policy) or in other countries (external price referencing).
  • Develop funding and reimbursement mechanisms (such as a reference price system) and tendering practices to complement pricing policies.
  • Foster good procurement practices, making explicit choices on the strategic treatment of award criteria, multiple winners and pooling volumes across procurers.
  • Shape demand in the health system by targeting key actors, in particular prescribers, pharmacists and patients, with tailored measures (e.g. prescribing guidelines and quotas for doctors, substitution policies for pharmacists).
  • Raise awareness of all stakeholder groups through information, education and capacity-building aligned to their needs.
• Successful implementation of biosimilar policies relies on a mix of supply- and demand-side measures implemented coherently at national, regional and local levels.
• A comprehensive policy to encourage the use of biosimilars would include additional steps to:
  • Introduce interface and multisectoral policies;
  • Actively manage the trade-offs between different measures (e.g. to achieve the desired level of competition while keeping the market attractive);
  • Foster skill-mix reform;
  • Capitalize on lessons from generic promotion and cross-country collaboration.
• There is substantial potential for cross-country learning because the policy packages applied in Europe have been so varied.
• The growing complexity of biological medicines makes it imperative that measures are constantly evaluated and adapted as evidence accumulates.