The US Food and Drug Administration has approved Mylan’s generic version of Teva’s blockbuster multiple sclerosis (MS) drug Copaxone.
Several companies have already developed their own versions of Copaxone (glatiramer acetate), but it is a lucrative market with a great deal of scope: the branded product is the most prescribed treatment for relapsing forms of MS in the US, with sales in the billions of dollars.
Mylan has gained FDA approval for its three-times-a-week 40 mg/mL generic injection – the first to have been given the nod by the US regulator – plus a once-daily 20 mg/mL version, both of which are indicated for the treatment of patients with relapsing MS.
Mylan says it will begin shipping the product soon – although FDA has not yet said whether it will have 180 days of exclusivity for the 40mg/mL version.
The announcement comes just days after the FDA launched plans to boost competition from complex generics as part of a bid to widen access to medicines.
"Mylan has invested tens of millions of dollars over many years to bring this important medicine to market,” says Mylan CEO Heather Bresch. “Providing patients, healthcare providers and caregivers with treatment options is very important when it comes to selecting the right therapy for relapsing forms of MS.”
She adds that the company is also offering a patient support programme, Mylan MS Advocate, which will focus on access to the therapy and adherence to the regimen. All patients prescribed Mylan’s generic can enrol in the initiative, which includes a mobile app, in-home injection training, a 24/7 patient support centre, co-pay assistance for eligible patients and ongoing nursing support.
The manufacturer’s Abbreviated New Drug Application included data demonstrating that its injected products have the same active ingredient, dosage form, route of administration and strength as their branded counterpart.