Related news and resources
Pharmacy-mediated substitution for biosimilars
Pharmacy-mediated substitution is a framework permitting substitution of medicines at the retail pharmacy without the consent of the prescribing physician. In 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.
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Global regulatory approaches to post-approval changes in biotherapeutic products
IFPMA worked with Clarivate to study how different countries regulate post-approval changes (PACs) in biotherapeutic products. The research compared PACs guidelines across 21 countries and regions in Latin America (LATAM), Asia-Pacific (APAC), and the Middle East and Africa (MEA) to the World Health Organization (WHO) Guidelines on changes on biotherapeutic products. The findings reveal significant diversity in the level of convergence among countries and with the WHO Reference Guidelines, with a few notable trends.
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Synthetic follow-on products that reference biologically produced medicines
The focus of this paper is follow-on versions of smaller protein products developed to be marketed following expiry of patent and data protection of the reference product. They are synthetically produced while the reference product is manufactured recombinantly.
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