FDA approves multiple sclerosis drugs from Mylan, including first generic for Copaxone®

Mylan N.V. has announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva’s Copaxone^® 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva’s Copaxone^® 20 mg/mL, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system. Mylan will begin shipping imminently.

"The FDA approvals of Mylan’s Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL as AP-rated, substitutable generics for Copaxone^® 20 mg/mL and 40 mg/mL, respectively, mark another significant milestone for our company, reinforce our proven capabilities in bringing complex and difficult-to-manufacture products to market, and further our commitment to providing access to high quality medicines," said Mylan CEO Heather Bresch.

"Mylan has invested tens of millions of dollars over many years to bring this important medicine to 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. Our commitment to the MS patient community extends beyond bringing generic versions of these products to market. We are also offering comprehensive patient support services to help patients access therapy as quickly as possible and adhere to a treatment regimen that fits their needs."

The FDA approved Mylan’s Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection and 20 mg/mL for once-daily injection as therapeutic AP-rated equivalents to Copaxone^® 40 mg/mL and Copaxone^® 20 mg/mL, respectively, meaning if they are substituted for their branded counterpart they can be expected to have the same clinical effect and safety profile. As part of its ANDAs, Mylan submitted rigorous side-by-side analyses, including characterization data, which demonstrated that its Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL have the same active ingredient, dosage form, route of administration and strength as their branded counterpart.

Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial MS diagnoses.