BIO weighs in with comments to US FDA on GPhA's biosimilar INN petition

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Same or different? How should biosimilars be named?
Same or different? How should biosimilars be named?
Industry group BIO has responded to a petition by the Generic Pharmaceutical Association (GPhA) in the latest bout of the debate over the international non-proprietary name (INN) for biosimilars.

Last September, the GPhA sent a citizen’s petition to the US Food and Drug Administration (FDA)​ urging for the use of identical INNs for biosimilars as their reference product, with CEO Ralph Neas saying the use of a different name “risks engendering confusion and would have a major negative impact throughout the global pharmaceutical supply chain.”

Biotechnology Industry organisation (BIO) – a group that represents 1,100 biotech related firms - has released a letter​ sent to the FDA on January 31 commenting on the petition, reiterating a number of the arguments it sent in a joint letter​ with the Pharmaceutical Research and Manufacturers of America (PhRMA) in 2012 against the use of the same INNs for biosimilars.

“Contrary to the GPhA Petition,”​ the letter said, “we believe that a system that assigns the same name to products that are similar, but not the same, would create confusion for physicians and patients, hinder effective pharmacovigilance, and could jeopardize patient safety.

“We believe it is possible to craft a nonproprietary naming convention that both contributes to patient safety through enhanced product identification and improves access to medicines at competitive prices.”

'No surprises'

BIOs views mirror those of a number of large industry players, including Johnson & Johnson who petitioned the FDA last month​ and, according to Howard Levine – President and Principal Consultant of BioProcess Technology Consultants – such lobbying is no surprise.

“The issue of naming biosimilars has been a controversial one almost from the beginning,”​ he told

“The large pharma and biotech companies who own the reference products coming off patent are obviously trying to do whatever they can to protect their franchises. You could have predicted that J&J, Genentech, Amgen, etc. would oppose the proposal to give biosimilars the same INN name as the reference product”

Pharmacovigilance issue?

Similarly, companies with biosimilar development programmes such as Hospira​, Novartis and Mylan, as well as the European Generics Association (EGA), have all come out on the same side as the GPhA, calling for uniformity.

Novartis, in fact, even went one stage further and told this publication in October​ the actions of a few originator companies may be using the INN debate to cast doubts around biosimilars.

Spokesperson Julie Masow said with public statements by biologics firms against sharing an INN, “these companies and their trade associations have positioned this as a pharmacovigilance issue”​ whereas Novartis – who makes biologics as well as biosimilars through its Sandoz subsidiary – feels “this argument does not have any merit as traceability of biosimilars does not require new or additional non-proprietary names.”

FDA's Response

As for the FDA, asked if the ongoing debate was damaging at all to the biosimilar approval process, but the agency declined to comment.

However, we were told as part of the consideration over appropriate naming for biosimilars the “FDA is carefully reviewing the comments on naming that various stakeholders have submitted to the public dockets established for FDA’s biosimilar draft guidances, FDA’s public hearing on biosimilars, and several citizen petitions related to biosimilar naming, or that otherwise have been submitted to the Agency.”

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