Warning letter causes delays for follow-on glatiramer acetate

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Warning letter causes delays for follow-on glatiramer acetate

Non‐Biological Complex Drugs/News | Posted 17/03/2017 0 Post your comment

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 17 February 2017 that Sandoz’s contracted fill/finish manufacturing partner, Pfizer, had received a US Food and Drug Administration (FDA) warning letter.

Momenta stated that approval of the abbreviated new drug application (ANDA) for its generic version of multiple sclerosis (MS) drug Copaxone (glatiramer acetate) will be dependent on resolution of Pfizer facility compliance issues. Therefore, the news is expected to cause a manufacturing delay for Momenta’s three-times-weekly Glatopa 40 mg injection.

Momenta said that ‘an approval in the first quarter of 2017 is unlikely’ but that it ‘is working with its collaboration partner Sandoz to resolve this matter in order to allow for an ANDA approval as soon as possible’.

FDA approved Momenta/Sandoz’s Glatopa 20 mg/mL injection once-daily MS therapy in April 2015 [1], as the first follow-on version of Teva Pharmaceutical Industries (Teva) blockbuster MS treatment Copaxone.

The news of the delay must come as a relief to Teva, who only received approval for the three-times-weekly formulation of Copaxone in January 2013. Teva has stated that ‘Copaxone 40 mg/mL is protected by two Orange Book patents that expire in 2030’ [2].

Follow-on glatiramer acetate gains European approval

References
1. 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 2017 Mar 17]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/News/FDA-approves-first-follow-on-version-of-glatiramer-acetate
2. 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 2017 Mar 17]. Available from: www.gabionline.net/Biosimilars/General/Teva-gains-FDA-approval-for-three-times-a-week-Copaxone

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Source: Momenta