Background: In 2014, six of the top ten blockbuster medicines were monoclonal\nantibodies. This multibillion-dollar market with expiring patents is the main driver for\nthe development of biosimilar mAbs. With the ever-increasing cost of healthcare and\nthe economic pressure to reduce or sustain healthcare expenses, biosimilars could be\ninstrumental in reducing costs for medication and increasing patient access to treatment.\nObjectives: The aim of this study is to identify and describe the barriers to market\naccess of biosimilar mAbs in the European Union and to analyze how these barriers\ncould be overcome.\nMethods: A narrative literature review was carried out using the databases PubMed,\nEmbase, and EconLit. Studies were published in English or Dutch. Additionally, the\nreference list of the articles was checked for relevant studies. Articles and conference\npapers known to the authors were included as well. Articles were also identified by\nsearching on the website of the Generics and Biosimilars Initiative (GaBI) journal.\nResults: Six barriers were identified based on available literature: The manufacturing\nprocess, the regulatory process, intellectual property rights, lack of incentive, the\nimpossibility of substitution, and the innovator�s reach. These six barriers are\npresented as a possible framework to study the market access of biosimilar mAbs.\nBased on the literature search, recommendations can be made to overcome these\nbarriers: (i) invest initially in advanced production processes with the help of singleuse\ntechnology, experience or outsourcing (ii) gain experience with the regulatory\nprocess and establish alignment between stakeholders (iii) limit patent litigation,\neliminate evergreening benefits, build out further the unitary patent and unified\npatent litigation system within the EU (iv) create demand-side policies, disseminate\nobjective information (v) change attitude toward biosimilar switching/substitution,\nstarting with physician, and patient education (vi) differentiate the biosimilar by\nservice offerings, use an appropriate comparator in cost-effectiveness analyses. Conclusions: Barriers to the market access of biosimilar mAbs could be reduced when\nmore transparency and communication/education is used in all steps toward market\naccess in order to increase the trust in biosimilar mAbs by all stakeholders. Only then\nbiosimilar mAbs will be able to fully capture their cost saving potential.
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