TABLE 3.

Examples of best practices in selected countries by key biosimilar policy area.

Policy area	Best practice examples
Manufacturing and R&D	European Union legislation streamlines preparation for biosimilar entry prior to the loss of exclusivity, enabling rapid launch post patent-expiry
Regulatory approval	The United Kingdom Medicines and Healthcare products Regulatory Agency no longer requires clinical comparability studies for all products given latest research regarding their lack of additional value to regulatory assessments
Health technology assessment	Many countries like the Netherlands waive the need for biosimilar health technology assessment provided the indications included in the biosimilar label are the same as the originator
Pricing and reimbursement	In the Netherlands, biosimilars can launch at the same price as their originators, encouraging entry, then competition is used to promote cost savings. Moreover, pricing and reimbursement are applied as a single process, ensuring biosimilars’ automatic reimbursement
Contracting	In the United Kingdom, long-term supply plurality is provided for adalimumab biosimilars, given that the market has been divided into 11 hospital groups. These groups are allocated a specific biosimilar or originator product, with degressive market shares for those products dependent on the competitiveness of the tender price they have offered
Biosimilar education and understanding	European educational campaigns spearheaded by the European Medicines Agency are often supplemented with national-level education in European countries, for example, at hospital/provider level to ensure holistic understanding of value across the country
Prescribing	In the United Kingdom, non-mandatory prescribing quotas still serve as an incentive for healthcare professionals. Moreover, gainsharing mechanisms implemented at some local Clinical Commissioning Groups have ensured that savings driven by biosimilars are reinvested in healthcare systems, improving their perception
Dispensing	In France, current dispensing policies do not undermine physicians’ autonomy but instead promote shared decision-making also with pharmacists. Moreover, substitution policies do not interfere with robust tracing systems used for safety monitoring (i.e. 95% of retail pharmacies are connected to the traceability tool - the “dossier pharmaceutique” - even though not all of them use it systematically), and patients can have their voices heard without any misconceptions around biosimilar value being able to influence dispensing decisions
Monitoring	The United States has pharmacovigilance systems ensuring full transparency in monitoring, for example, by assigning a suffix to the biosimilar name in regulatory documents to distinguish between different biosimilars