Synthon’s generic version of Copaxone at 40mg receives European approval to treat MS


Netherlands-based pharmaceutical company Synthon’s 40mg/ml of glatiramer acetate has received regulatory approval for the treatment of relapsing forms of multiple sclerosis (MS) in Europe.

MS is an unpredictable, often disabling disease of the central nervous system that disturbs the flow of information within the brain, and between the brain and body.

The approval followed the company’s successful completion of the decentralised procedures for pre-filled syringe glatiramer acetate at 40mg/ml.

The Synthon treatment can be administered three times a week and is a therapeutically equivalent version of Teva Pharmaceutical Industries’ originator medicine Copaxone at 40mg.

The company has received regulatory clearance for glatiramer acetate at 40mg/ml in all 27 member states

Synthon received regulatory clearance in all 27 member states of the European Union, including Iceland, Liechtenstein, and Norway.

Synthon chief executive officer Jacques Lemmens said: “We are very pleased with this approval. It allows us to make an affordable version of the 40mg/ml dosage strength of glatiramer acetate available to MS patients in Europe.”

"We are very pleased with this approval. It allows us to make an affordable version of the 40mg/ml dosage strength of glatiramer acetate available to MS patients in Europe."

In April last year, Synthon’s glatiramer acetate injection at 20mg/ml received approval in Europe for the treatment of relapsing-remitting multiple sclerosis (RRMS) and is already available in several European markets.

RRMS is the most common form of MS in which the patient suffers from clear episodes of inflammatory activity known as relapses, followed by remission.

Synthon is Mylan’s European partner of glatiramer acetate injection products at 20mg/ml and 40mg/ml.

Mylan has exclusive distribution and supply rights for the products for Germany, France, Spain, Portugal, Belgium, Italy, the Netherlands, the UK, Ireland, Switzerland, Greece, Denmark, Sweden, Norway, Finland, Cyprus and Malta.


Image: Photomicrograph of a demyelinating MS-Lesion. Photo: courtesy of Marvin 101 via Wikipedia.