Policy considerations for the development, regulation and adoption of biosimilars

Biosimilars can play a role in expanding patient access to biological medicines and in supporting the sustainability of healthcare systems. To fully realize this potential, IFPMA recommends the adoption of the following policy recommendations.

Strengthen regulatory alignment and capacity building

• Promote international cooperation and global convergence to uphold science-based quality, efficacy and safety standards (such as WHO guideline on biosimilars), and facilitate reliance
• Support training and technical resources for National Regulatory Authorities (NRAs)
• Foster reliance and mutual recognition agreements where feasible

Promote clear and science-based substitution policies

• Encourage clear and case-by-case switching and substitution determinations
• Safeguard informed physician and patient decision-making in pharmacy substitution frameworks

Ensure robust pharmacovigilance and traceability systems

• Implement globally distinguishable naming and batch tracking
• Strengthen adverse event reporting infrastructure
• Engage all stakeholders in real-time signal detection and risk mitigation

Ensure transparency for healthcare providers and patients

• Develop training activities for healthcare providers
• Support clear, consistent communication tools for patients