Brabio (glatiramer acetate injection), the first generic alternative to Copaxone for relapsing multiple sclerosis (MS) patients, was recently launched in the U.K. at an equivalent higher dose, its maker, Mylan, announced.
Similar to Copaxone — developed by Teva — Brabio is now available at a 40 mg/ml dose. Both medications are intended to be taken three times per week and at least 48 hours apart.
Brabio is expected to be sold at a lower cost than Copaxone, as the U.K.’s National Health Service (NHS) is aiming to broaden the use of best-value therapies within its Medicines Value Programme. This program aims to improve health outcomes while keeping costs affordable.
Research estimates that over 100,000 people have MS in the U.K., with the highest prevalence being observed in Scotland. About 6,000 new cases are diagnosed each year.
“Bringing a more affordable, more accessible treatment option to market for patients with [MS] has been a priority for Mylan,” Jacek Glinka, president of Mylan Europe, said in a press release. “We are dedicated to this important patient community and continued efforts to bring lower-cost, high-quality therapeutic equivalent versions of Copaxone to market in the UK and around the world.”
The launch of Brabio follows the U.K. Court of Appeal’s refusal this month to accept Teva’s request for an appeal of earlier ruling by the country’s High Court of Justice in favor of Mylan and its partner Synthon. All claims of infringement related to Teva’s U.K. patent covering Copaxone 40 mg/mL were found invalid. This decision made Brabio’s launch at this dose possible in the U.K.
Synthon is responsible for developing and supplying Mylan’s European glatiramer acetate injection products, with exclusive rights across Europe. The medication’s high dose (40 mg/mL) was granted marketing authorization in multiple European markets in October 2017. A lower dose (20 mg/mL), taken once/day, had been launched earlier across the continent.
The U.S. Food and Drug Administration approved both lower and higher doses of Mylan’s generic versions of Copaxone in October 2017.
Results from a Phase 3 study (NCT01489254), called Glatiramer Acetate Clinical Trial to Assess Equivalence With Copaxone or GATE, were important to these approvals. The study, which ended in early 2015, showed that that the generic glatiramer acetate formulation had equivalent efficacy to Copaxone in adults with relapsing MS. The generic version reduced brain lesions similar to the brand-name treatment, and showed a positive safety and tolerability profile.
A study reporting GATE results was published in JAMA Neurology in December 2015.