Copaxone Generic Approved for Multiple Sclerosis

The US Food and Drug Administration (FDA) has approved Abbreviated New Drug Applications (ANDAs) for generic versions of 2 different Copaxone injection doses for relapsing forms of multiple sclerosis (MS).

The generics — Glatiramer Acetate 40 mg/mL for 3-times-a-week injection, and 20 mg/mL for daily injection — are produced by pharmaceutical company Mylan. Their approval as an efficacy-equivalent to Copaxone makes waves in the MS treatment market, as the Teva-produced drug was the most prescribed treatment for relapsing forms of the neurological condition in the past year.

Copaxone brand sales equated to over $4 billion combined for the 2 dosage rates for the 12 months ending July 31, according to QuintilesIMS. The generic version is coming to a market of about 400,000 US patients with MS — 85% of whom suffer from a relapsing form.

Mylan chief executive officer Heather Bresch said that Mylan has invested “tens of millions of dollars” over years to bring the generic medicines to the market.

“Providing patients, healthcare providers and caregivers with treatment options is very important when it comes to selecting the right therapy for relapsing forms of multiple sclerosis,” Bresch said. “Our commitment to the MS patient community extends beyond bringing generic versions of these products to market.”

The company is additionally introducing the Mylan MS Advocate, a patient support program that will aid patients prescribed to either Glatiramer Acetate Injection regimens. The program includes a mobile app, in-home injection training, a round-the-clock support center, MS nurse support and co-pay assistance.

Mylan was one of the first applicants to submit a complete ANDA for Glatiramer Acetate Injection, 40 mg/mL, according to its FDA approval letter. Mylan and other first filers could therefore be eligible for 180 days of generic drug exclusivity. The formal decision is pending FDA ruling.

At the time of the approval, Mylan is awaiting decision on another 225 ANDAs submitted to the FDA. The potential generics represent a total of $92.5 billion in annual brand sales, according to QuintilesIMS. Mylan could be susceptible to 180-day generic drug exclusivity for 44 of these pending ANDAs.

According to the company, 1 of every 13 prescriptions filled in the US is a Mylan product.