Impax announces FDA approval of follow-on sevelamer carbonate

Non‐Biological Complex Drugs/News | Posted 17/11/2017 post-comment0 Post your comment

US generics maker Impax Laboratories (Impax) announced on 23 October 2017 that it had received final US Food and Drug Administration (FDA) approval for its abbreviated new drug application (ANDA) for a follow-on version of Renvela (sevelamer carbonate).

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Sevelamer is classified as a non-biological complex drug (NBCD), but since there are currently no guidelines for ‘follow-on’ versions of NBCDs, such drugs are approved under the generics or hybrid pathways. However, due to their complexity and the fact that they cannot be fully quantitated, characterized or described by (physico)chemical analytical tools, some groups have said that the generics and hybrid pathways for these products may not be appropriate, and have called for regulatory guidelines for follow-on versions of NBCDs [1].

The originator product Sanofi’s Renvela (sevelamer carbonate) is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Sevelamer carbonate tablets had US brand name and follow-on version sales of approximately US$1.9 billion, according to IMS Health for the 12 months ending August 2017.

Impax has gained approval for its follow-on version of the tablets at a dosage of 800 mg and says that it ‘has immediately initiated commercialization activities’.

Follow-on versions of sevelamer carbonate tablets 800 mg were also approved by FDA from Aurobindo Pharma and Dr Reddy’s Laboratories in July and September 2017, respectively.

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1. GaBI Online - Generics and Biosimilars Initiative. Guidelines needed for follow-on versions of NBCDs []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 17]. Available from:

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Source: US FDA, Impax

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