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Biosimilar product labels in Europe: what information should they contain?

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Biosimilar product labels in Europe: what information should they contain?

Introduction

Labels on medicinal products contain information for pharmacists, physicians and patients. This information is presented in the Summary of Product Characteristics (SmPC), the Patient Leafl et (PL) and the immediate label on the outer product packaging, referred to as ‘labelling’ in this paper.

Biological medicines (biologicals) are complex molecules, often proteins, though they may contain also sugars or nucleic acids, and are manufactured in, extracted from, or semi-synthesized from biological sources. Biosimilar medicines are defined in the European Union (EU) as a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product) in the European Economic Area (EEA) [1]. Due to the similarity, yet difference, between originator biologicals and biosimilars, questions have been raised about current EU labelling practice for biosimilar medicines.

Fuente: Gabi Journal

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