The World Health Organization (WHO) has emphasized the importance of communication, trust and education in order to increase patient access to biosimilars in high-income countries. The issues were discussed by Emer Cooke, Head of the Regulation of Medicines and other Health Technologies Department, at the 17th Biosimilar Medicines Conference.
Although the number of safe and high quality biosimilars are increasing in high-income countries, their use remains limited. This is due to problems with acceptance by healthcare systems, doctors and patients, in some cases due to myths around the quality of biosimilar drugs compared to their brand-name counterparts.
Regulatory inconsistencies also impede biosimilar use. Regulatory approval pathways in some countries differ to those of the major regulatory regions, which can lead to a lack of trust.
At the 17th Biosimilar Medicines Conference in The Netherlands, WHO Department for the Regulation of Medicines and other Health Technologies (RHT) outlined several key factors that could increase the use of biosimilar drug products, including:
• Collaboration
Collaboration, such as joint assessments and collaborative registration, can help to increase experience and promote reliance, which is especially important for less experienced National Regulatory Authorities (NRAs).
• Communication
Communicating the appropriate information to policymakers, professionals and patients is important to increase acceptance of biosimilars.
• Education
Similarly, evidence-based findings are important to debunk the myths surrounding biosimilars and build trust in them as safe and effective treatment options. In Europe, the European Medicines Agency provides information on biosimilars for healthcare professionals [1] and patients [2], while in the US the Food and Drug Administration has launched a public educational campaign around biosimilars [3].
Through a range of regulatory activities – such as harmonization of pharmacopeia, the global benchmarking tool [4], post-marketing surveillance and prequalification programmes [5], – WHO aims to contribute to these efforts and ultimately increase patient access to biosimilars.
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References
1. European Medicines Agency. Biosimilars in the EU. Information guide for healthcare professionals [homepage on the Internet]. [cited 2019 May 3]. Available from: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf
2. European Commission. Information for patients: what I need to know about biosimilar medicines [homepage on the Internet]. [cited 2019 May 3]. Available from: https://ec.europa.eu/growth/content/information-patients-what-i-need-know-about-biosimilar-medicines-0_en
3. US Food and Drug Administration. Biosimilars [homepage on the Internet]. [cited 2019 May 3]. Available from: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm
4. GaBI Online - Generics and Biosimilars Initiative. WHO Global Benchmarking Tool Revision VI includes ‘Listed Authorities’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 3]. Available from: www.gabionline.net/Reports/WHO-Global-Benchmarking-Tool-Revision-VI-includes-Listed-Authorities
5. GaBI Online - Generics and Biosimilars Initiative. WHO to launch prequalification programme for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 3]. Available from: www.gabionline.net/Biosimilars/General/WHO-to-launch-prequalification-programme-for-biosimilars
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