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Biosimilars and market access: a question of comparability and costs?

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This article discusses specific issues related to the market access of biosimilars. Biopharmaceuticals are complex molecules produced by living cells. Copies of these medicines, called biosimilars, are not identical to their reference medicine and therefore specific regulatory requirements apply. When considering the use of biosimilars, the question of the degree of comparability between a biosimilar and the reference biopharmaceutical needs to be considered for registration, pricing and reimbursement purposes in addition to the cost issue. To date, many key concepts (like clinically meaningful differences) remain undefined and the question of the degree of comparability is not yet resolved.

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Conflict of interest statement

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. SS holds the EGA chair “European policy towards generic medicines”. The authors have no conflicts of interest that are directly relevant to the content of this manuscript.

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Correspondence to Steven Simoens.

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This article is a reprint of “Market access of biosimilars: not only a cost issue”, Oncologie (2011) 13: 218–221.

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Simoens, S., Verbeken, G. & Huys, I. Biosimilars and market access: a question of comparability and costs?. Targ Oncol 7, 227–231 (2012).

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