Launch timelines for Cipla’s long-awaited generic (g) Advair (salmeterol/fluticasone) in the US now hinge on whether its Indore site in India makes the compliance cut, but the firm claimed that even if things don’t go its way, the value proposition for the product remains unaltered.
Cipla's Advair Generic US Debut May Be Pushed Out But 'Value Intact'
Cipla to pursue two-site, de-risked filing approach for large respiratory assets even as it awaits an FDA compliance classification for its Indore facility, which will determine the launch timelines for its much-awaited generic Advair in the US.
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With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.