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

Non‐Biological Complex Drugs/Research | Posted 29/07/2016 post-comment0 Post your comment

Despite the difficulties associated with evaluating follow-on versions of non-biological complex drugs (NBCDs), the rigorous approach used by the US Food and Drug Administration (FDA) was able to establish the sameness of a follow-on glatiramer acetate (Glatopa) compared to Copaxone, according to researchers from Momenta Pharmaceuticals, the Northwestern University Feinberg School of Medicine and Kantor Neurology [1].


Teva Pharmaceutical Industries’ blockbuster once-daily multiple sclerosis (MS) therapy Copaxone (glatiramer acetate) was approved by FDA back in December 1996. In April 2015, FDA approved the first follow-on version of glatiramer acetate (Glatopa) from Sandoz/Momenta Pharmaceuticals [2]. Importantly, it was also approved as the first therapeutically equivalent or ‘AP-rated’ substitutable follow-on NBCD for treating patients with MS.

Copaxone is classified as an 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 [3]. The European Medicines Agency (EMA) has responded to such concerns by publishing reflection papers for NBCDs in the form of follow-on versions of iron-based nano-colloidal products and intravenous liposomal products [4].

Despite the complexity of Glatopa, an abbreviated new drug application (ANDA) approach was used and equivalence to Copaxone was evaluated across four criteria, without the need for additional clinical data:
• starting materials and basic chemistry
• structural signatures for polymerization, depolymerization and purification
• physicochemical properties
• biological and immunological properties.

According to researchers Anderson et al., no differences were observed in structure or function between Glatopa and Copaxone, as measured using more than 45 physicochemical methods and more than 15 biological and immunological assays. In addition to these multiple analyses, as part of the approval process under the ANDA pathway, independent testing by FDA laboratories confirmed the equivalence of Glatopa and Copaxone.

The researchers/authors concluded that ‘the approval of Glatopa by the FDA as fully substitutable for Copaxone 20 mg demonstrates that by using advanced analytics paired with extensive process knowledge, equivalence to the brand product for a complex mixture such as glatiramer acetate is achievable’.

Conflict of interest
The authors of the research paper [1] declared that Momenta Pharmaceuticals funded the research mentioned in the paper. For full details of the authors’ conflicts of interest, see the research paper [1].

Editor’s comment
Readers interested to learn more about 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

The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead?

Readers interested in contributing a research paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

Related article
Follow-on glatiramer acetate (M365) claimed as equivalent to Copaxone

1. Anderson J, Bell C, Bishop J, Capila I, Ganguly T, Glajch J, et al. Demonstration of equivalence of a generic glatiramer acetate (Glatopa™). J Neurol Sci. 2015;359(1-2):24-34.
2. 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 2016 Jul 29]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/News/FDA-approves-first-follow-on-version-of-glatiramer-acetate
3. GaBI Online - Generics and Biosimilars Initiative. Guidelines needed for follow-on versions of NBCDs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 29]. Available from: www.gabionline.net/Reports/Guidelines-needed-for-follow-on-versions-of-NBCDs
4. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for follow-on NBCDs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 29]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/Guidelines/EU-guidelines-for-follow-on-NBCDs

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