Zydus Lifesciences Limited announced on Thursday that it has received final approval from the United States Food and Drug Administration (USFDA) for its Glatiramer Acetate Injection, a generic version of Copaxone® in 20 mg/mL and 40 mg/mL strengths.
The injection, developed in collaboration with Italy-based Chemi S.p.A., will be manufactured entirely in Europe and is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive disease in adults.
The product has been classified as an AP-rated substitutable generic, making it an approved alternative to Copaxone®, which recorded annual sales of USD 719 million in the U.S. market as of March 2025, according to IQVIA data.
“This approval underscores Zydus’ leadership in bringing complex, differentiated generics to market,” said Dr. Sharvil Patel, Managing Director of Zydus Lifesciences. “Together with Chemi, we are proud to expand access to this important therapy.”
Punit Patel, President & CEO of Zydus Pharmaceuticals USA Inc., added that the approval “showcases our expertise in developing complex medications and reinforces our dedication to providing accessible, high-quality healthcare solutions.”
With this approval, Zydus now has a total of 426 final ANDA approvals out of 492 filings since the beginning of its regulatory submissions in FY2003-04.
