FDA approves 40 mg follow-on version of glatiramer acetate

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FDA approves 40 mg follow-on version of glatiramer acetate

Non‐Biological Complex Drugs/News | Posted 09/03/2018 0 Post your comment

Sandoz, the generics division of Novartis, announced on 13 February 2018 the approval of its 40 mg follow-on version of glatiramer acetate by the US Food and Drug Administration (FDA).

Glatopa (glatiramer acetate) 40 mg/mL is a fully substitutable, AP-rated generic version of the originator product, Teva Pharmaceutical’s (Teva) Copaxone (glatiramer acetate).

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].

Sandoz’s three-times-a-week therapy for patients with relapsing forms of multiple sclerosis (MS), Glatopa, has been available in a 20 mg dosage since 2015 [3]. However, approval of the double dosage was put on hold in 2017 due to contamination issues. The newly approved 40 mg dosage is not expected to be launched before 2019. The approval comes as a result of Sandoz’s collaboration with fellow generics maker Momenta Pharmaceuticals (Momenta).

Rival generics maker Mylan also had a 40 mg follow-on version of glatiramer acetate approved by FDA in October 2017.

Rigorous approach used to approve a follow-on version of glatiramer acetate

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 2018 Mar 9]. 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 2018 Mar 9]. 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 approves first follow-on version of glatiramer acetate [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 9]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/News/FDA-approves-first-follow-on-version-of-glatiramer-acetate

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Source: Sandoz, US FDA