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Regul Toxicol Pharmacol. 2016 Jun;77:275-81. doi: 10.1016/j.yrtph.2016.03.021. Epub 2016 Apr 1.

Physicians prefer greater detail in the biosimilar label (SmPC) - Results of a survey across seven European countries.

Author information

1
SFL Regulatory Affairs & Scientific Communication Ltd, Basel, Switzerland. Electronic address: a.hallersten@sfl-services.com.
2
SFL Regulatory Affairs & Scientific Communication Ltd, Basel, Switzerland.
3
EuropaBio, Brussels, Belgium.

Abstract

In the European Union, labels (Summaries of Product Characteristics, SmPCs) of biosimilars and their reference products are in many instances almost identical (following a generic approach) despite different data requirements for the authorization of biosimilars and generics. To understand physicians' preferences on type and detail of information in the biosimilar label and their use of information sources when prescribing biologics including biosimilars, EuropaBio surveyed 210 physicians across seven European countries. Among surveyed physicians, 90.5% use the label frequently or occasionally as an information source and 87.2% deemed a clear statement on the origin of data helpful or very helpful. When comparing excerpts from the label of an authorized biosimilar and modified texts with additional information, 78.1-82.9% preferred the samples with additional information. This survey shows that the label is an appropriate vehicle for providing physicians with information about biologics and that physicians prefer more product-specific information in the biosimilar label.

KEYWORDS:

Biosimilars; Labelling survey; Physician preference; Regulatory requirements

PMID:
27041395
DOI:
10.1016/j.yrtph.2016.03.021
[Indexed for MEDLINE]
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