Evidence to support the interchangeability of hybrid generic glatiramer (Brabio®) with the original branded version (Copaxone®)

David Erskine, Director, London Medicines Information Services, Specialist Pharmacy ServicePublished

Glatiramer is licensed for the treatment of relapsing forms of multiple sclerosis (MS). A generic version (Brabio®) has recently been launched in the UK which reduces the treatment cost by around £2000 per patient per year. Brabio was licensed as a hybrid generic medicine which in this case meant that due to difficulties demonstrating pharmacokinetic equivalence the regulator required additional clinical studies to be conducted. To support the application for license the manufacturer conducted a clinical equivalence study in 729 patients randomised to the branded version (Copaxone®), the generic version (Brabio®) or placebo. After 9 months follow-up patients still in the trial and receiving either the branded version or placebo were switched to generic glatiramer and outcomes were compared with patients continued on the generic version over a further 15 months of follow up. The investigators demonstrated that the generic version was therapeutically equivalent to the branded version and was similarly well tolerated. Similarly no differences were seen in safety, efficacy or antibody titres between patients were switched from branded to the generic version after 9 months and patients maintained on generic versions for a further 15 months follow up.
Therefore it is concluded that there is robust evidence to support the case for switching patients from branded to generic glatiramer as a means of reducing treatment costs without compromising safety or effectiveness.