Mylan N.V. 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. Mylan also is 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 Mylan’s 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. Mylan’s Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL are available by prescription only.
According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete ANDA for Glatiramer Acetate Injection, 40 mg/mL, containing a Paragraph IV certification. Therefore, Mylan and other first filers may be eligible for 180 days of generic drug exclusivity but FDA has not made a formal determination on exclusivity at this time.
In addition, Mylan is introducing Mylan MS AdvocateTM, a comprehensive patient support service program to help patients get started on and stay on track with their physician’s treatment plan for either dose strength of Mylan’s Glatiramer Acetate Injection. All patients prescribed and taking Mylan’s Glatiramer Acetate Injection 3-times-a-week 40 mg/mL or once-daily 20 mg/mL are eligible to enroll in the program which includes an interactive mobile app, in-home injection training, a 24/7 patient support center, co-pay assistance for eligible patients and ongoing support from an MS-experienced nurse.
Copaxone is the most prescribed MS treatment for relapsing forms of MS in the United States with brand sales for the 20 mg/mL dose of approximately $700 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending July 31, 2017, according to QuintilesIMS. Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial MS diagnoses.
Currently, Mylan has 225 ANDAs pending FDA approval representing approximately $92.5 billion in annual brand sales, according to QuintilesIMS. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $41.9 billion in annual brand sales, for the 12 months ending July 31, 2017, according to QuintilesIMS. Currently, one out of every 13 prescriptions filled in the U.S. – brand-name or generic – is a Mylan product.
GLATIRAMER ACETATE INJECTION is a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (MS).
Filed Under: Drug Discovery