FDA approves new generic version of relapsing MS therapy Copaxone
New generic developed by Zydus Lifesciences with Chemo S.p.A.
The U.S. Food and Drug Administration (FDA) has approved a new generic form of glatiramer acetate injection, a treatment for relapsing forms of multiple sclerosis (MS) that was originally approved under the brand name Copaxone.
The generic was developed by Zydus Lifesciences in collaboration with Chemi S.p.A., which belongs to the Italfarmaco Group.
“Zydus, together with Chemi, is proud to receive FDA approval for a substitutable generic version for this important therapy,” Sharvil Patel, PhD, managing director of Zydus Lifesciences, said in a company press release. “This approval underscores Zydus’ leadership in bringing complex, differentiated generics to market, reinforcing our commitment to providing a comprehensive range of therapeutic choices for patients.”
Punit Patel, president and CEO of Zydus Pharmaceuticals USA, said the approval “showcases our expertise in developing complex medications and reinforces our dedication to providing accessible, high-quality healthcare solutions.”
Generic medications contain ingredients that are chemically identical to name-brand therapies and are held to the same safety and quality standards. Generics are usually cheaper than their name-brand counterparts and because they introduce more competition into the marketplace, their availability can help drive down drug costs. Zydus didn’t specify how much the new generic will cost.
Copaxone and its generics
Copaxone, which has been approved in the U.S. since the 1990s, is marketed by Teva Pharmaceuticals. Other generic versions of glatiramer acetate injection have been approved, including one from Sandoz and one from Mylan Pharmaceuticals. Copaxone and generic versions of glatiramer acetate injection are indicated to treat relapsing types of MS, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).
The new generic will be available in single-dose prefilled syringes at 20 mg/mL and 40 mg/mL. Copaxone and generic versions of glatiramer acetate are administered by injection under the skin, or subcutaneously, at either 20 mg/mL daily or 40 mg/mL three times a week.
MS is an inflammatory disorder wherein the immune system attacks healthy tissue in the brain and spinal cord, disrupting normal neurological signaling and leading to disease symptoms. MS is marked by damage to the myelin sheath, a fatty covering that wraps around nerve fibers and helps nerves send electrical signals, sort of like rubber insulation around a copper wire.
Glatiramer acetate is a human-made molecule that’s designed to mimic a piece of the myelin sheath. It was first discovered when researchers were exploring ways to induce MS-like disease in animal models, but found that the molecule actually prevented MS-like disease from developing, leading to its development as a treatment. The therapy’s mechanism of action isn’t completely understood, but it’s thought to reduce the inflammatory attack that drives MS.
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