Biosimilar drugs should have different non-proprietary names to their branded counterparts, says the European industry body EuropaBio in a statement filed with the World Health Organisation.
The WHO held a meeting earlier this week to debate the issues related to the naming of biologicals and biosimilar medicines, and EuropaBio, along with four other partner organisations, has been lobbying to get its views represented in the agency’s deliberations on traceability.
The biotech industry has long maintained that it is crucial to differentiate biosimilars from the innovator drug, and indeed from each other, in order to allow accurate post-marketing surveillance and trace any product-related problems back to the source.
The European Medicines Agency (EMEA) also seems to concur with this view, saying recently that “due to the complexity of biological/biotechnology-derived products, the generic approach is scientifically not appropriate for these products.”
Separate names would bypass the possible problem of pharmacist substitution of biologic drugs. Substitution of a generic for a proprietary medicine is allowed in some EU countries such as Germany and Sweden, even if a doctor has specified the brandname drug. As biosimilars are not considered identical to the innovator, this should not occur without consultation with the prescriber, it is argued.
