Generic Glatiramer Acetate Injection Approved for Multiple Sclerosis
The Food and Drug Administration (FDA) has approved a new formulation of generic glatiramer acetate injection for the treatment of multiple sclerosis (MS), according to an announcement from ScinoPharm Taiwan (Tainan, Taiwan). Glatiramer acetate is an established disease-modifying therapy (DMT) for the treatment of MS and has been approved in the United States since 1996 under the brand name Copaxone (glatiramer acetate injection; Teva, Tel Aviv-Yafo, Israel), with the generic Glatopa (glatiramer acetate injection; Sandoz, Basel, Switzerland) approved in 2015. The newly approved product represents an additional FDA-approved generic option for patients with MS.
Glatiramer acetate is classified as a nonbiological complex drug, reflecting its chemical and structural complexity. Unlike conventional small-molecule drugs, glatiramer acetate is a heterogeneous mixture of synthetic polypeptides with variable amino acid sequences and molecular weights. Because it lacks a single, well-defined molecular structure, the product cannot be fully characterized using standard analytical methods. As a result, FDA review of generic glatiramer acetate relies on extensive analytical characterization, manufacturing process controls, and biological activity assays to demonstrate equivalence to the reference listed drug, Copaxone.
According to a press release from ScinoPharm Taiwan, development of the approved generic required validation of manufacturing consistency and stability across numerous process parameters, supported by advanced analytical methods and statistical modeling. The FDA has established a dedicated regulatory pathway for nonbiological complex drugs, such as glatiramer acetate, to address these challenges in demonstrating therapeutic equivalence.
In January 2025, the FDA added a Boxed Warning for risk of anaphylactic reactions to the label of glatiramer acetate.
Source: ScinoPharm Taiwan. ScinoPharm secures U.S. FDA approval for glatiramer acetate injection for the treatment of multiple sclerosis. PR Newswire. Published January 5, 2025. Accessed January 5, 2025. https://prnmedia.prnewswire.com/news-releases/scinopharm-secures-us-fda-approval-for-glatiramer-acetate-injection-for-the-treatment-of-multiple-sclerosis-302652370.html