FDA approves Lupin’s generic clobazam and Dr Reddy's launches follow-on sevelamer carbonate Posted 08/02/2019

By end of 2018, Lupin Pharmaceuticals Inc received US Food and Drug Administration (FDA) approval for its clobazam oral suspension, 2.5 mg/mL, and Dr Reddy's Laboratories Ltd (Dr Reddy) launched its sevelamer carbonate for oral suspension.

On 31 December 2018, Lupin announced that it had received approval from FDA to market its clobazam oral suspension, 2.5 mg/mL, a generic version of Lundbeck Pharmaceuticals LLC’s Onfi Oral Suspension, 2.5 mg/mL. Clobazam oral suspension, 2.5 mg/mL is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients aged two years or older. Lennox-Gastaut Syndrome is a severely debilitating form of generalized paediatric epilepsy that begins in early childhood and is characterized by recurrent seizures and slow mental development.

According to IQVIA data from September 2018, clobazam oral suspension, 2.5 mg/mL had annual sales of approximately US$260.2 million in the US.

Dr Reddy's announced on 27 December 2018 the launch of its sevelamer carbonate for oral suspension, a generic version of Sanofi’s Renvela, in the US market. Sevelamer carbonate for oral suspension is used to control serum phosphorus in patients with chronic kidney disease on dialysis. It will be available in 0.8 g and 2.4 g packets in count size of 90. 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 [1-3].

IMS Health estimated Renvela brand and generic US sales to be approximately US$101 million for the 12 months ending in October 2018.

Related article
In vitro analysis of follow-on versions of sevelamer

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 2019 Feb 8]. Available from: www.gabionline.net/Reports/Guidelines-needed-for-follow-on-versions-of-NBCDs
2. GaBI Online - Generics and Biosimilars Initiative. Impax announces FDA approval of follow-on sevelamer carbonate [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 8]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/News/Impax-announces-FDA-approval-of-follow-on-sevelamer-carbonate 
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves follow-on version of sevelamer [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 8]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/News/FDA-approves-follow-on-version-of-sevelamer

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