Majority of EU member states say ‘no’ to INNs for biosimilars
A majority said that separate INNs (International Nonproprietary Names) for biosimilars would be “contrary to such an alignment” as some member states said that these INNs could “undermine the trust of healthcare professionals and the public.”
“The same INN should be used for both the reference medicinal products and the biosimilar medicinal products,” the committee wrote.
Some stakeholders, however, underlined the importance of the INN for the traceability of biosimilars and biologics and how to attribute an adverse reaction reports to the correct biological medicinal product.
But as far as traceability, member states in general “answered that both branded name and INN are reported, that batch number is often reported (frequency seems to vary between member states) and that it is not problematic to identify the biological medicinal products which are the subject of adverse reaction reports.”
The battle over how biosimilars should be named has raised eyebrows across industry as some have said the discussion raises doubts on pharmacovigilance.
The EU move comes as the US FDA seems to remain on the fence over when biosimilars should be approved, even as the EU has approved at least 10. Pre-emptive state legislation also seems to be hampering the onslaught of biosimilars in the US.
But researchers at Frost & Sullivan recently indicated that politics and the FDA are not the only reasons that biosimilars have been slow to the US market. Scientifically ensuring the interoperability of biosimilars and biologics seems to be another key issue.
