Dutch MEB position on prescription of biosimilar medicinal products

7 April 2015

The Netherlands’ Medicines Evaluation Board (MEB) has updated its position about biosimilar medicinal products, saying that biosimilars have been proven to have no relevant differences compared to an innovator biological medicinal product as far as quality, safety and efficacy are concerned.

The MEB adopted a position about biosimilars in 2010. At the time, the agency was of the opinion that patients must be kept on a biological medicinal product as much as possible if they respond well to it clinically.

Based on a careful study of the most recent literature and experiences in the evaluation of biosimilars, the MEB deems that this strict condition is no longer valid. There is enough evidence to support the use of biosimilars in clinical practice, provided this occurs with caution and under certain conditions. However, these conditions are essential.

Conditions for permitting biosimilar products

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