In 2016, Synthon successfully concluded the decentralized procedures for glatiramer acetate 20 mg/mL, a therapeutically equivalent version of the originator product Copaxone® for the treatment of RRMS in Europe. All 29 member states included in the decentralized procedures supported approval of the product.
The authorities' approval formally acknowledges that Synthon's glatiramer acetate is regarded therapeutically equivalent to the reference product based on the Quality, Non-Clinical and Clinical data submitted in the application.
Synthon conducted a large-scale, multicenter Phase III study, known as GATE (Glatiramer Acetate clinical Trial to assess Equivalence to Copaxone®). Results of the study demonstrate equivalence in efficacy and safety and support the safety of switching active therapy from Copaxone® to Synthon's glatiramer acetate. Synthon is the only company to have performed such a study for glatiramer acetate and to have obtained regulatory clearance in Europe.
Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results (Multiple Sclerosis Journal, 2017/01)
Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis A Randomized Clinical Trial (JAMA Neurology, 2015/12)
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, unpredictable and progressive disease of the central nervous system that causes inflammation and destruction of the myelin sheath – the protective layer that surrounds the body’s nerve fibers. This destruction may result in cognitive impairment, physical disability and fatigue.
According to the National MS Society, MS affects more than 2.5 million people worldwide. Relapsing remitting multiple sclerosis (RRMS) affects about 85 percent of the MS population. RRMS is characterized by clearly defined flare-ups followed by periods of partial or complete recovery or remission.
Press releases on GATE study
12 April 2016
Synthon obtains approval for glatiramer acetate 20mg/mL in Europe.
3 August 2015
Pfizer and Synthon enter into U.S. commercialization agreement for potential generic treatment of Multiple Sclerosis
28 April 2015
Synthon announces successful outcomes from the open-label extension of the Phase III GATE study of Synthon's glatiramer acetate
9 October 2014
Synthon announces filing of glatiramer acetate 40mg/mL ANDA containing a paragraph IV certification
27 March 2014
Synthon announces successful outcome of the Phase III GATE study with its generic glatiramer acetate