{"id":11596,"date":"2025-01-17T10:00:52","date_gmt":"2025-01-17T09:00:52","guid":{"rendered":"http:\/\/ifpma.org\/?post_type=publications&#038;p=11596"},"modified":"2025-01-17T10:26:34","modified_gmt":"2025-01-17T09:26:34","slug":"pharmacy-mediated-substitution-for-biosimilars","status":"publish","type":"publications","link":"https:\/\/www.ifpma.org\/publications\/pharmacy-mediated-substitution-for-biosimilars\/","title":{"rendered":"Pharmacy-mediated substitution for biosimilars"},"content":{"rendered":"<p class=\"intro\">This position paper addresses substitution relating to biosimilars and their reference products at the retail pharmacy level.<\/p>\n<p>Pharmacy-mediated substitution is a framework permitting substitution of medicines at the retail pharmacy without the consent of the prescribing physician.\u00a0In this paper, we outline a set of principles that can guide pharmacy-mediated substitution. While the principles are intended for the awareness of pharmacists, they can also relate to other healthcare providers, regulators, payers, and those involved in formulary and procurement decision-making.<\/p>\n<h3 class=\"underline\">Recommendations<\/h3>\n<p>Patient safety and access to medicines are critical in the context of pharmacy-mediated substitution, especially when it comes to biologic products including biosimilars.\u00a0The position paper outlines the following principles:<\/p>\n<ul>\n<li>A structured science-based framework should be in place for the regulatory evaluation of pharmacy-mediated substitution.<\/li>\n<li>The prescribing physician should have the right to state on a prescription, \u201cdo not substitute\u201d or \u201cdispense as written\u201d or some other statement that recognises no substitution must occur.<\/li>\n<li>Pharmacy-mediated substitution for biosimilars should only be granted if data is available to demonstrate that repeated switching between the reference product and the biosimilar is not associated with a higher risk than continuous treatment with the reference product. This data may come from a switching study but in some cases, it may not be necessary such as:<\/li>\n<li>the product is not for chronic use.<\/li>\n<li>the product is a less complex protein where clinical experience with the reference product and its class shows that the immunogenic potential is low.<\/li>\n<li>Pharmacy-mediated substitution should only occur for the indications for which the biosimilar can be marketed (e.g., not excluded by intellectual property rights).<\/li>\n<li>The patient should be able to use the medical device associated with the biosimilar without supervision from the prescribing physician or nurse.<\/li>\n<li>Measures to ensure traceability (the unique identification) of the biological\/biosimilar medicine including batch number handed out to the patient at the pharmacy are particularly important for pharmacovigilance when implementing pharmacy-mediated substitution with biosimilars.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pharmacy-mediated substitution is a framework permitting substitution of medicines at the retail pharmacy without the consent of the prescribing physician.\u00a0In this paper, IFPMA outlines a set of principles that can guide pharmacy-mediated substitution. While the principles are intended for the awareness of pharmacists, they can also relate to other healthcare providers, regulators, payers, and those involved in formulary and procurement decision-making.<\/p>\n","protected":false},"featured_media":16862,"template":"","publication_type":[7],"topic":[28,26],"class_list":["post-11596","publications","type-publications","status-publish","has-post-thumbnail","hentry","publication_type-position-paper","topic-biotherapeutics","topic-regulatory-convergence-and-reliance"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pharmacy-mediated substitution for biosimilars | IFPMA<\/title>\n<meta name=\"description\" content=\"Pharmacy-mediated substitution is a framework permitting substitution of medicines at the retail pharmacy without the consent of the prescribing physician.\u00a0In this paper, IFPMA outlines a set of principles that can guide pharmacy-mediated substitution. While the principles are intended for the awareness of pharmacists, they can also relate to other healthcare providers, regulators, payers, and those involved in formulary and procurement decision-making.\" \/>\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\/pharmacy-mediated-substitution-for-biosimilars\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmacy-mediated substitution for biosimilars | IFPMA\" \/>\n<meta property=\"og:description\" content=\"Pharmacy-mediated substitution is a framework permitting substitution of medicines at the retail pharmacy without the consent of the prescribing physician.\u00a0In this paper, IFPMA outlines a set of principles that can guide pharmacy-mediated substitution. While the principles are intended for the awareness of pharmacists, they can also relate to other healthcare providers, regulators, payers, and those involved in formulary and procurement decision-making.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.ifpma.org\/publications\/pharmacy-mediated-substitution-for-biosimilars\/\" \/>\n<meta property=\"og:site_name\" content=\"IFPMA\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/IFPMA\/\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-17T09:26:34+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.ifpma.org\/wp-content\/uploads\/2025\/01\/Copy-of-Publications-Portrait-cover-1.png\" \/>\n\t<meta property=\"og:image:width\" content=\"634\" \/>\n\t<meta property=\"og:image:height\" content=\"896\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@IFPMA\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.ifpma.org\/publications\/pharmacy-mediated-substitution-for-biosimilars\/\",\"url\":\"https:\/\/www.ifpma.org\/publications\/pharmacy-mediated-substitution-for-biosimilars\/\",\"name\":\"Pharmacy-mediated substitution for biosimilars | IFPMA\",\"isPartOf\":{\"@id\":\"https:\/\/www.ifpma.org\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.ifpma.org\/publications\/pharmacy-mediated-substitution-for-biosimilars\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.ifpma.org\/publications\/pharmacy-mediated-substitution-for-biosimilars\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.ifpma.org\/wp-content\/uploads\/2025\/01\/Copy-of-Publications-Portrait-cover-1.png\",\"datePublished\":\"2025-01-17T09:00:52+00:00\",\"dateModified\":\"2025-01-17T09:26:34+00:00\",\"description\":\"Pharmacy-mediated substitution is a framework permitting substitution of medicines at the retail pharmacy without the consent of the prescribing physician.\u00a0In this paper, IFPMA outlines a set of principles that can guide pharmacy-mediated substitution. 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