FDA Approves Generic Glatiramer Acetate Injection for Multiple Sclerosis Treatment

According to a new announcement, the FDA has approved ScinoPharm Taiwan’s glatiramer acetate (GA) injection as a treatment for relapsing multiple sclerosis (MS), making it the first complex injectable generic approval for this therapy.¹

GA, originally marketed as Copaxone in 1996, has been recognized as one of the most challenging complex synthetic polypeptides globally. This newly approved version is a non-biological complex drug (NBCD) generic, meaning it has the same active, route, and typical strengths of traditional GA, mirroring the Copaxone label.

To date, there are no publicly registered phase 2/3 MS trials under ScinoPharm’s name and no mention of human efficacy trials in their FDA-approval press communications. Instead, the company–and the FDA–emphasized that the product followed the non-biological complex drug ANDA pathway described in FDA’s product-specific guidance for GA. That guidance allows waiving traditional clinical bioequivalence trials if the generic demonstrates tight structural and compositional matching, as well as in vitro and in-vivo functional similarity.

While Scino’s new GA formulation has the same active ingredient, indications, and route/dosing as Copaxone, some of the key differences are with the manufacturer and process. For context, ScinoPharm noted it uses its own proprietary synthesis and purification process for the GA polymer, further stressing their capabilities in complex peptide manufacture and stringent quality control. Like other GA generics, ScinoPharm’s injection must be Q1/Q2-matched or very close to Copaxone, but minor differences in syringe design, needle gauge, or packaging are allowed.

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Some of the best clinical evidence that a high-quality generic can match brand Copaxone is the GATE trial (NCT01489254), published in JAMA Neurology in 2015. This multicenter, double-blind, randomized, active- and placebo-controlled phase 3 study included 794 patients with relapsing-remitting MS, using total number of gadolinium-enhancing (Gd) MRI lesions at months 7-9.²

Overall, results showed that the generic GA and brand Copaxone had equivalent efficacy on MRI and similar relapse rates. In the published data, the estimated mean numbers of Gd-enhancing lesions with generic drug and brand drug were lower than placebo (ratio, 0.488; 95% CI, 0.365-0.651; P <.001), confirming study sensitivity. For Gd-enhancing lesions, the estimated ratio of generic drug to brand drug was 1.095 (95% CI, 0.883-1.360), which was within the predefined equivalence margin of 0.727 to 1.375.

In early 2024, the FDA issued a complete response letter for Mapi Pharma’s GA Depot, a long-acting, once-monthly GA solution as a potential treatment for relapsing MS. The drug’s supportive phase 3 study (NCT04121221), a double-blind, placebo-controlled trial, showed that treatment with GA Depot led to statistically significant reductions in annualized relapse rate relative to placebo (P = .0066) over a 52-week period.³

REFERENCES
1. ScinoPharm Secures U.S. FDA Approval for Glatiramer Acetate Injection for the Treatment of Multiple Sclerosis. News release. ScinoPharm. January 5, 2025. Accessed January 5, 2025. https://www.prnewswire.com/news-releases/scinopharm-secures-us-fda-approval-for-glatiramer-acetate-injection-for-the-treatment-of-multiple-sclerosis-302652370.html
2. Cohen J, Belova A, Selmaj K, et al. Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2015;72(12):1433-41. doi:10.1001/jamaneurol.2015.2154.
3. Viatris and Mapi Pharma Statement Regarding New Drug Application for GA Depot. News Release. Viatris. Published March 11, 2024. Accessed January 5, 2025. https://newsroom.viatris.com/press-releases?item=123816