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FDA approves first follow-on version of glatiramer acetate Posted 05/11/2015

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 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: 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
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?
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
Source: Sandoz, US FDA
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