Common or distinct INN for biosimilars? Only characteristics of the active substance prior to formulation should be considered
Journal Title: Generics and Biosimilars Initiative Journal - Year 2014, Vol 3, Issue 1
Abstract
To the Editor: I read with interest the letter of Dr Edward T Maggio which was published in Volume 2/Year 2013/Issue 4 of the Generics and Biosimilars Initiative Journal [1] on the naming issue for biosimilars and traceability of immunogenicity. He states that during storage of a biological drug product the active substance may undergo aggregation and oxidation. Dr Maggio also states that these processes are influenced by excipients such as polysorbates. In the context of the currently hot debate on the designation of the International Nonproprietary Name (INN) of biosimilars it is concluded by the author that biosimilars should be given an INN that is distinct from the INN of the reference product. The arguments are based on the fact that the formulation of the biosimilar is different from that of the reference product, subsequently leading to distinct product-related variants over time in both drug products. This may then result in a different safety profile. I would like to point out that any given INN is based on the structural characteristics of the purified active substance prior to formulation. Any subsequent modifications that happen during or after formulation or storage should not be the subject of the INN. I therefore feel that in the discussions on whether or not the active substance of a biosimilar should be given a distinct INN, neither the formulation nor possible changes upon storage should be taken into account.
Authors and Affiliations
Paul J Declerck
Keywords
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- EP ID EP354127
- DOI 10.5639/gabij.2014.0301.003
- Views 86
- Downloads 0
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