US generics giant Mylan announced on 23 January 2018 that it had launched Brabio, the first follow-on version of Teva Pharmaceutical’s (Teva) Copaxone (glatiramer acetate) in the UK.
Brabio 40 mg/mL is indicated for the treatment of relapsing forms of multiple sclerosis, a chronic inflammatory disease of the central nervous system.
The news follows a ruling by the UK Court of Appeals in January 2018 in favour of Mylan and its European partner Synthon. The decision revoked the patent for Teva’s synthesis of the active ingredient in Copaxone [1], a key drug used to treat recurring multiple sclerosis, finding all claims of Teva’s patent in question ‘invalid based on obviousness’.
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 in assessing public health safety and clinical efficacy, and have called for regulatory guidelines for follow-on versions of NBCDs [2].
Netherlands-based generics and biopharmaceuticals company Synthon gained European approval for its follow-on glatiramer acetate product in April 2017 after successfully concluding decentralized procedures [3].
The company is expected to offer Brabio to the UK’s National Health Service (NHS) at a lower price than Copaxone. The NHS is currently seeking to expand its use of best value medicines following the launch of its ‘Medicines Value Programme’. This initiative aims to improve health outcomes by diverting budget to other areas of need without compromising on treatment.
The US Food and Drug Administration approved its first follow-on version of glatiramer acetate injection (Sandoz’s Glatopa) in April 2016 [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Synthon prevails over Copaxone patent dispute [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 15]. Available from: www.gabionline.net/Pharma-News/Synthon-prevails-over-Copaxone-patent-dispute
2. 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 Feb 15]. Available from: www.gabionline.net/Reports/Guidelines-needed-for-follow-on-versions-of-NBCDs
3. GaBI Online - Generics and Biosimilars Initiative. Follow-on glatiramer acetate gains European approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 15]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/News/Follow-on-glatiramer-acetate-gains-European-approval
4. 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 Feb 15]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/News/FDA-approves-first-follow-on-version-of-glatiramer-acetate
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