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EuropaBio Calls for More Transparency of Biosimilar Labels
EuropaBio has developed recommendations for changes to the Summary of Product Characteristics (SmPC) of biosimilars that would result in an enhanced level of transparency in the label.
EuropaBio members believe that the current EU approach to labeling does not reflect the specificities of biosimilars and that the SmPC of a biosimilar product should contain additional information to facilitate greater transparency for physicians and patients.
Based on interactions that EuropaBio had with various stakeholders including physicians and patients over recent years, we have concluded that label transparency would be enhanced by implementing the following small yet meaningful changes to the biosimilar SmPC:
- Adding a statement with the definition of biosimilarity
- Adding a direct link to the EPAR next to the biosimilarity statement
- Moving the biosimilarity statement to the top of the SmPC
“The EMA and the European Commission are going to great lengths to increase physicians’ and patients’ understanding of biosimilars”, said Ronald Jager, EuropaBio Healthcare Biotech Director, “We are convinced that a more transparent labeling approach would contribute to further facilitate the understanding and acceptance of biosimilars.”
Yescarta Demonstrates Promise in Treating Relapsed/Refractory Large B-Cell Lymphoma
December 9th 2024Real-world evidence from the largest analysis of second-line treatment with Yescarta in 2022-2023 demonstrated a high overall survival rate in patients with relapsed/refractory large b-cell lymphoma.
FDA Grants Priority Review to AstraZeneca’s Imfinzi for Muscle-Invasive Bladder Cancer
December 6th 2024The FDA based the Priority Review designation on results from the Phase III NIAGARA trial, which found that Imfinzi reduced the risk of disease progression, recurrence, or death by 32% in patients with muscle-invasive bladder cancer.
