EU Group Calls for Greater Transparency in Labelling Biosimilars
June 9, 2017
EU regulators who want to encourage understanding and acceptance of biosimilar medicines might consider improving the drugs’ labels. So says the stakeholders group EuropaBio, which has issued recommendations for enhancing transparency in the literature that accompanies a biosimilar.
Known as the summary of product characteristics, this documentation is required by the European Commission to authorize marketing a drug. But it also guides health care providers on how to use the medication. And currently, EuropaBio contends, such summaries lack information that providers need. The group suggests improving the literature by:
- Adding a statement with the definition of biosimilarity
- Adding a direct link to the drug’s public assessment report next to the biosimilarity statement
- Moving the biosimilarity statement to the top of the summary document.
These changes could better convey biosimilar’s specificities, EuropaBio explained in a statement. Biosimilars are highly similar but not identical to their biologic reference product, a distinction that can impact patients’ response to biosimilars as well as their physicians’ prescribing decisions.
As EuropaBio’s healthcare biotech director Ronald Jager explained, “The EMA and the European Commission are going to great lengths to increase physicians’ and patients’ understanding of biosimilars. We are convinced that a more transparent labelling approach would contribute to further facilitate the understanding and acceptance of biosimilars.”
Biosimilar labeling also remains a topic of discussion among U.S. regulators and stakeholders. The U.S. Food and Drug Administration’s guidance, still in draft form, would require a biosimilar’s label to carry a statement of biosimilarity. It also would require a subsection that explains how applying the reference product’s data on antibody development directly to the biosimilar may be “misleading” – acknowledging the complexity of biological drugs’ impact on the immune system.
EuropaBio says that its recommendations, which reflect conversation with physicians and patients, can inform regulators and stakeholders’ next steps.Tags: Biologics, Regulatory Issues
Categorized in: Blog