Novartis petition reignites biosimilar naming debate

Novartis petition reignites biosimilar naming debate Last week the dispute over the naming of Biosimilars was reignited as heavyweights Novartis joined the debate.

Last week the dispute over the naming of Biosimilars was reignited as heavyweights Novartis joined the debate.

Calls by the Alliance for Safe Biological Medicines (ASBM), back in September 2012, for the FDA to give biosimilar medicines distinct scientific names started this debate. Citing possible differences in effects between bisimilar drugs, and the general belief amongst physicians and specialists that products with the same scientific name were structurally identical, the ASBM presented their concerns regarding switching drugs during treatment.

But last week saw Novartis join the likes of the Generic Pharmaceutical Association (GPhA) and Hospira in their opposition to the proposed change. In a Citizen Petition, Novartis outlined it's concern that any changes to the IPP names (International non-proprietary names) convention could have a detrimental effect on biosimilar's ability to compete within the market.

Their objections include:

  • Any change to the current naming convention would undermine consumer confidence in biosimilar products, as well as the system at large.
  • Inconsistencies in naming would lead to medication and prescription errors, putting patients at risk.
  • IPP names are designed to identify the active pharmaceutical agent, not to distinguish between individual products.
  • With robust drug safety systems in place, there is no need to resort to name changes to differentiate products

Are these objections sound? Should the possibility of harm raised by the ASBM take precedent over any previous naming system? Or are these safety concerns merely inflated? Continue the debate on Linkedin.

Interested in this debate? Then you may well be interested in attending the World Biosimilar Conference Europe 2013 (November 12-13), or Biosimilar Drug Development World Americas 2013 (November 19-21)

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About the Author

About the Author: Despite holding a degree in philosophy, I've a taste for the scientific and the experimental. With interests in innovation, experimentation and business strategy within the life sciences you will find me writing for Vaccine Nation, Total Orphan Drugs, and Total BioPharma .


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