The US Food and Drug Administration (FDA) announced on 16 April 2015 the approval of the first follow-on version of glatiramer acetate injection used to treat patients with relapsing forms of multiple sclerosis (MS).
Sandoz’s Glatopa is the first substitutable follow-on version of Teva Pharmaceutical Industries (Teva)’s blockbuster 20 mg/mL once-daily MS therapy Copaxone (glatiramer acetate injection). The approval comes as a result of Sandoz’s collaboration with fellow generics maker Momenta Pharmaceuticals (Momenta).
MS is a debilitating disease affecting about half a million individuals in the US alone, and Sandoz estimates that only half of those diagnosed are currently treated.
Copaxone 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 pathway. 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 pathways may not be appropriate and have called for regulatory guidelines for follow-on versions of NBCDs [1]. The European Medicines Agency has responded to such concerns with the adoption of its first reflection paper for NBCDs in the form of follow-on versions of iron-based nano-colloidal products [2].
The Momenta/Sandoz collaboration also announced in August 2014 that they had had abbreviated new drug application for their three-times-weekly follow-on version of glatiramer acetate injection 40 mg/mL product accepted for filing by FDA [3]. This news came despite the fact that Teva only received approval for the three-times-weekly formulation of Copaxone in January 2013 and has stated that ‘Copaxone 40 mg/mL is protected by two Orange Book patents that expire in 2030’ [4].
Editor’s Comment
Please feel free to share your thoughts via email or in the comments section below. What are your views on regulatory approval for follow-on versions of NBCDs? Do you think that a separate regulatory pathway is required?
Readers interested to learn more about follow-on versions of NBCDs are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Non-Biological Complex Drugs (NBCDs) and their follow on versions (generics): time for an editorial section
Defining and characterizing non-biological complex drugs (NBCDs) – Is size enough? The case for liposomal doxorubicin generics (‘liposomal nanosimilars’) for injection
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.
Related article
Non-biological complex drug concept: experiences with iron sucrose and low molecular weight heparin
References
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 2015 Nov 6]. Available from: www.gabionline.net/Reports/Guidelines-needed-for-follow-on-versions-of-NBCDs
2. GaBI Online - Generics and Biosimilars Initiative. EMA issues draft reflection paper for iron-based nano-colloidal products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 6]. Available from: www.gabionline.net/Guidelines/EMA-issues-draft-reflection-paper-for-iron-based-nano-colloidal-products
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts applications for three-times-weekly follow-on Copaxone [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-applications-for-three-times-weekly-follow-on-Copaxone
4. GaBI Online - Generics and Biosimilars Initiative. Teva gains FDA approval for three-times-a-week Copaxone [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 6]. Available from: www.gabionline.net/Biosimilars/General/Teva-gains-FDA-approval-for-three-times-a-week-Copaxone
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