26 September 2018 - Mylan and Novartis are taking issue with the fact that the US 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.

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