FDA approves generic injection to help manage MS
Scinopharm’s glatiramer acetate is generic of Copaxone
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- The FDA approved Scinopharm's generic glatiramer acetate injection for MS.
- This generic version of Copaxone treats relapsing forms of the disease.
- It reduces relapses and lesions, and may delay disability progression.
The U.S. Food and Drug Administration (FDA) has approved Scinopharm Taiwan’s glatiramer acetate injection, a generic of Copaxone, to treat multiple sclerosis (MS).
Scinopharm is the first pharmaceutical company in Taiwan to win U.S. approval for glatiramer acetate, marking a significant milestone for the country in the global industry, according to a company press release.
In addition to the brand-name medication Copaxone, which is marketed by Teva Pharmaceuticals, several generics are also approved in the U.S. Like other versions, Scinopharm’s generic is available as a solution for subcutaneous (under-the-skin) injection. It comes in two strengths: 20 mg/mL and 40 mg/mL.
MS is a long-term disease in which the immune system mistakenly attacks healthy tissue in the brain and spinal cord. This can cause a range of symptoms, such as problems with movement, vision, and sensation. About 2.9 million people live with MS globally, and there are nearly 1 million patients in the U.S., according to Scinopharm.
Glatiramer acetate is a disease-modifying treatment approved for use in adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. It helps reduce relapses and lesions, and evidence has shown that it may also delay disability progression.
Redirecting cells
While its exact mechanism of action is unclear, glatiramer acetate is thought to work as a decoy, redirecting immune cells away from healthy nerve cells. It does not contain a single molecule, but a mixture of small protein chains, called peptides, with different lengths and sequences. This means it lacks a fixed structure or weight, making quality control particularly challenging.
To ensure glatiramer acetate generics work the same as the brand-name medication, companies must carefully control every step of production. More than 40 advanced testing methods, along with statistical analysis and biological activity tests, are used to confirm that the complex generic is indeed comparable to the reference drug.
Only a few companies worldwide possess the scientific and manufacturing expertise necessary to produce glatiramer acetate successfully. Scinopharm said the FDA’s approval shows it can compete with leading global pharmaceutical companies and has opened the door to a large market — $700 million in the U.S. alone.
The company said it is preparing regulatory filings and partnerships in Europe, Asia, and other regions to “build on its already strong position” in generics.
