Mylan and Novartis to FDA: Where are the Suffixes?

Regulatory NewsRegulatory News | 26 September 2018 |  By 

Mylan and Novartis are taking issue with the fact that the US Food and Drug Administration (FDA) has yet to begin issuing random suffixes for biologics’ names and so far has only used suffixes for biosimilars and a few recently approved biologics, according to comments released Wednesday.

“The agency has not yet retroactively issued suffixes to any reference product for which there is a corresponding biosimilar. Given the agency's silence about this practice, there are senior scientists and prominent physicians in the US that believe that this disparity is intentional,” Novartis said in its comment on the recent biosimilar meeting at FDA.

Novartis’ Sandoz has launched its filgrastim biosimilar Zarxio (filgrastim-sndz) but noted that in 65 case reports since its launch, 62 (95%) included the biosimilar’s brand name, whereas none used the -sndz suffix.

“We urge that the agency carefully review such pharmacovigilance data as it becomes available. If the data reveals that pharmacovigilance has been negatively impacted, the agency should place the interests of patients first and reverse the decision to add suffixes to the non-proprietary name of biologics,” Novartis said.

Similarly, Mylan requested that FDA eliminate the suffixes.

"If FDA is unwilling to do so, however, we ask that FDA move expeditiously to help level the playing field by ensuring that all reference drugs also carry suffixes," Mylan said in its comment.

The misimpression that only biosimilars have suffixes “undermines FDA’s finding that the reference drug and the biosimilar have the same clinical effect and safety profile. Reference drug companies have tried hard to reinforce this erroneous perception,” Mylan added.


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