An international comparative analysis and roadmap to sustainable biosimilar markets.

Autor:	Alnaqbi KA; Tawam Hospital, College of Medicine and Health Sciences, UAE University, Al Ain, United Arab Emirates., Bellanger A; Pitié Salpétrière Hospital, Sorbonne University, Paris, France., Brill A; Matrix Global Advisors, American Enterprise Institute, Washington, DC, United States., Castañeda-Hernández G; Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, Mexico City, Mexico., Clopés Estela A; Catalan Institute of Oncology, Barcelona, Spain., Delgado Sánchez O; Espases University Hospital, Palma de Mallorca, Spain., García-Alfonso P; Medical Oncology Department, Gregorio Marañón General University Hospital, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Universidad Complutense, Madrid, Spain., Gyger P; Independent Consultant, Zurich, Switzerland., Heinrich D; Innlandet Hospital Trust, Gjøvik, Norway., Hezard G; Nile, Paris, France., Kakehasi A; Federal University of Minas Gerais (UFMG), Belo Horizonte, Brazil., Koehn C; Arthritis Consumer Experts, Vancouver, BC, Canada., Mariotte O; Nile, Paris, France., Mennini F; Economic Evaluation and HTA (EEHTA), CEIS, Faculty of Economics, University of Rome 'Tor Vergata', Rome, Italy., Mayra Pérez-Tapia S; Unidad de Investigacion, Desarollo e Innovacion Médica y Biotecnológica (UDIMEB), Unidad de Desarollo e Investigacion de Bioterapeuticos (UDIBI), Instituto Politécnico Nacional, Ciudad de México, Mexico., Pistollato M; Charles River Associates, London, United Kingdom., Saada R; Charles River Associates, London, United Kingdom., Sasaki T; Showa University, Shinagawa, Japan., Tambassis G; Australian Biosimilars Academy, Sydney, NSW, Australia., Thill M; Department of Gynecology and Gynecological Oncology, Agaplesion Markus Hospital, Frankfurt, Germany., Werutsky G; Hospital São Lucas PUCRS, Porto Alegre, Brazil., Wilsdon T; Charles River Associates, London, United Kingdom., Simoens S; KU Leuven, Leuven, Belgium.
Jazyk:	angličtina
Zdroj:	Frontiers in pharmacology [Front Pharmacol] 2023 Aug 24; Vol. 14, pp. 1188368. Date of Electronic Publication: 2023 Aug 24 (Print Publication: 2023).
DOI:	10.3389/fphar.2023.1188368
Abstrakt:	Background: Although biosimilar uptake has increased (at a variable pace) in many countries, there have been recent concerns about the long-term sustainability of biosimilar markets. The aim of this manuscript is to assess the sustainability of policies across the biosimilar life cycle in selected countries with a view to propose recommendations for supporting biosimilar sustainability. Methods: The study conducted a comparative analysis across 17 countries from North America, South America, Asia-Pacific, Europe and the Gulf Cooperation Council. Biosimilar policies were identified and their sustainability was assessed based on country-specific reviews of the scientific and grey literature, validation by industry experts and 23 international and local non-industry experts, and two advisory board meetings with these non-industry experts. Results: Given that European countries tend to have more experience with biosimilars and more developed policy frameworks, they generally have higher sustainability scores than the other selected countries. Existing approaches to biosimilar manufacturing and R&D, policies guaranteeing safe and high-quality biosimilars, exemption from the requirement to apply health technology assessment to biosimilars, and initiatives counteracting biosimilar misconceptions are considered sustainable. However, biosimilar contracting approaches, biosimilar education and understanding can be ameliorated in all selected countries. Also, similar policies are sometimes perceived to be sustainable in some markets, but not in others. More generally, the sustainability of the biosimilar landscape depends on the nature of the healthcare system and existing pharmaceutical market access policies, the experience with biosimilar use and policies. This suggests that a general biosimilar policy toolkit that ensures sustainability does not exist, but varies from country to country. Conclusion: This study proposes a set of elements that should underpin sustainable biosimilar policy development over time in a country. At first, biosimilar policies should guarantee the safety and quality of biosimilars, healthy levels of supply and a level of cost savings. As a country gains experience with biosimilars, policies need to optimise uptake and combat any misconceptions about biosimilars. Finally, a country should implement biosimilar policies that foster competition, expand treatment options and ensure a sustainable market environment. Competing Interests: GC-H has received consultancy and speaker fees from AbbVie, Amgen, Janssen-Cilag, Libbs, Novartis, Pfizer, Roche, Sanofi, Takeda, and UCB. OM and GH work at Nile, secretary general of the French think tank “Biosimilaires” and have links of interest with Accord Healthcare, Amgen, Biogen, and Sandoz. MT has received personal honoraria for lectures and participation in advisory boards from Amgen, Medscape, Jörg Eickeler, Onkowissen, Organon, Pfizer, Viatris, Vifor. He received manuscript support by Amgen, Roche, Servier and travel expenses by Amgen, Hexal, I-Med-Institute, Pfizer, Roche. Congress support was given by Amgen, Hexal, Pfizer, Roche. TW, MP, and RS were commissioned to support the project that informed this analysis and they assume editorial responsibility as contributors to the study. Charles River Associates is an economic consultancy company. SS is one of the founding members of the KU Leuven Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL Fund). SS was involved in a stakeholder roundtable on biologics and biosimilars sponsored by Amgen, Pfizer and MSD, and he has participated in advisory board meetings for Amgen, Pfizer, Organon and Sandoz. He has contributed to studies on biologics and biosimilars for Hospira, Celltrion, Mundipharma and Pfizer; and he has had speaking engagements for Amgen, Celltrion, Organon and Sandoz. Author AB was employed by Matrix Global Advisors. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. (Copyright © 2023 Alnaqbi, Bellanger, Brill, Castañeda-Hernández, Clopés Estela, Delgado Sánchez, García-Alfonso, Gyger, Heinrich, Hezard, Kakehasi, Koehn, Mariotte, Mennini, Mayra Pérez-Tapia, Pistollato, Saada, Sasaki, Tambassis, Thill, Werutsky, Wilsdon and Simoens.)
Databáze:	MEDLINE
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