{"id":18251,"date":"2025-10-27T14:28:56","date_gmt":"2025-10-27T13:28:56","guid":{"rendered":"https:\/\/www.ifpma.org\/?post_type=publications&#038;p=18251"},"modified":"2025-10-27T14:29:20","modified_gmt":"2025-10-27T13:29:20","slug":"policy-considerations-for-the-development-regulation-and-adoption-of-biosimilars","status":"publish","type":"publications","link":"https:\/\/www.ifpma.org\/publications\/policy-considerations-for-the-development-regulation-and-adoption-of-biosimilars\/","title":{"rendered":"Policy considerations for the development, regulation and adoption of biosimilars"},"content":{"rendered":"<p>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.<\/p>\n<p><strong>Strengthen<\/strong> <strong>regulatory alignment and capacity building<\/strong><\/p>\n<ul>\n<li>Promote international cooperation and global convergence to uphold science-based quality, efficacy and safety standards (such as WHO guideline on biosimilars), and facilitate reliance<\/li>\n<li>Support training and technical resources for National Regulatory Authorities (NRAs)<\/li>\n<li>Foster reliance and mutual recognition agreements where feasible<\/li>\n<\/ul>\n<p><strong>Promote clear and science-based substitution policies<\/strong><\/p>\n<ul>\n<li>Encourage clear and case-by-case switching and substitution determinations<\/li>\n<li>Safeguard informed physician and patient decision-making in pharmacy substitution frameworks<\/li>\n<\/ul>\n<p><strong>Ensure robust pharmacovigilance and traceability systems<\/strong><\/p>\n<ul>\n<li>Implement globally distinguishable naming and batch tracking<\/li>\n<li>Strengthen adverse event reporting infrastructure<\/li>\n<li>Engage all stakeholders in real-time signal detection and risk mitigation<\/li>\n<\/ul>\n<p><strong>Ensure transparency for healthcare providers and patients<\/strong><\/p>\n<ul>\n<li>Develop training activities for healthcare providers<\/li>\n<li>Support clear, consistent communication tools for patients<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>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 a series of policy recommendations.\u00a0<\/p>\n","protected":false},"featured_media":0,"template":"","publication_type":[7],"topic":[67,28,26,27,62],"class_list":["post-18251","publications","type-publications","status-publish","hentry","publication_type-position-paper","topic-access-to-medicines","topic-biotherapeutics","topic-regulatory-convergence-and-reliance","topic-therapeutical-products","topic-universal-health-coverage"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Policy considerations for the development, regulation and adoption of biosimilars | IFPMA<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ifpma.org\/publications\/policy-considerations-for-the-development-regulation-and-adoption-of-biosimilars\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Policy considerations for the development, regulation and adoption of biosimilars | IFPMA\" \/>\n<meta property=\"og:description\" content=\"Biosimilars can play a role in expanding patient access to biological medicines and in supporting the sustainability of healthcare systems. 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