FDA approves follow-on version of sevelamer

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FDA approves follow-on version of sevelamer

Non‐Biological Complex Drugs/News | Posted 30/06/2017 0 Post your comment

Indian generics maker Aurobindo Pharma (Aurobindo) announced on 15 June 2017 that it had received US Food and Drug Administration (FDA) approval for its follow-on version of sevelamer.

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].

Aurobindo’s product (sevelamer carbonate oral suspension) is a therapeutic equivalent generic version of Genzyme’s Renvela oral suspension. It has been approved in 0.8 g and 2.4 g dosages and is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

Renvela had sales of US$140 million for the 12 months ending April 2017, according to IMS data.

Aurobindo is one of the top 10 companies in India in terms of revenue. The company exports to over 125 countries across the globe with more than 70% of its revenues derived out of international operations. The company now has a total of 323 abbreviated new drug application (ANDA) approvals (288 final approvals including 16 from Aurolife Pharma LLC and 35 tentative approvals) from FDA.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Guidelines needed for follow-on versions of NBCDs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 30]. Available from: www.gabionline.net/Reports/Guidelines-needed-for-follow-on-versions-of-NBCDs

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Source: BSE