Mylan and its development partner Synthon have received European regulatory approval for a new generic version of the multiple sclerosis drug Copaxone.
The new generic glatiramer acetate 40 mg/mL injection treatment is therapeutically equivalent to the branded version of Copaxone, created by Teva, and is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
“Mylan and Synthon have received European marketing authorisation for a new generic version of the multiple sclerosis therapy Copaxone.“
Heather Bresch, chief executive officer of Mylan, said: "This approval reinforces our commitment to helping patients and healthcare providers by providing alternative treatment options to better serve the needs of this community."
A 20 mg/mL version of the generic drug was approved in Europe last year and has already been made available in several European markets. Granting of national marketing approvals of the 40 mg/mL version is expected in the near future.
Synthon is the developer and supplier of both products, while Mylan has exclusive distribution and supply rights for the therapies in the UK, Ireland, Germany, France, Spain, Italy, the Netherlands and many other European nations.
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