In Blow to Teva, EU Approves Synthon’s Generic Version of Copaxone to Treat RRMS

In Blow to Teva, EU Approves Synthon’s Generic Version of Copaxone to Treat RRMS

Synthon’s prefilled syringe with 40 mg/ml of glatiramer acetate — the generic version of Teva Pharmaceutical’s Copaxone 40 mg — has received regulatory clearance in all 28 member states of the European Union (EU) plus Iceland, Liechtenstein and Norway to treat relapsing-remitting multiple sclerosis (RRMS).

The low-dose formulation of 20 mg/ml glatiramer acetate developed by Synthon is available in most of these countries since the end of 2016. Now the Dutch pharmaceutical company will seek national marketing authorizations for its 40 mg/ml pre-filled syringes of generic glatiramer acetate.

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

This regulatory decision comes after the European Patent Office decided in favor of Synthon in a patent litigation with Israel’s Teva, allowing Synthon to produce and market its generic version of Copaxone.

While many drug companies are developing generic versions of Copaxone, Synthon is the only one that performed a large-scale Phase 3 clinical trial (NCT01489254) to evaluate both efficacy and safety of its generic glatiramer acetate relative to Teva’s Copaxone.

The “Glatiramer Acetate Clinical Trial to Assess Equivalence With Copaxone” (GATE) trial randomly assigned 794 RRMS patients to receive daily injections of 20 mg of generic glatiramer acetate, 20 mg of Copaxone, or placebo for up to nine months.

The trial showed that Synthon’s generic glatiramer acetate and Teva’s Copaxone were equally safe, tolerable and efficient. Clinical data supported the approval of marketing applications submitted to both the U.S Food and Drug Administration and the European Medicines Agency .

An additional 15-month extension of the GATE trial further demonstrated the two medication’s similarities. Follow-up clinical data showed that the therapeutic effects of generic glatiramer acetate were sustained over two years of treatment. In addition, patients had no issues when switching from branded to generic formulation.

Under an established collaboration agreement, Pfizer holds all U.S. commercial rights to Synthon’s glatiramer acetate.

3 comments

  1. Jaz says:

    Am I missing something, why a blow, got it, the blow is to the company, but wait I did not even know who makes Capaxone, only that it isthe name of the medication I am prescibed, made me wonder how much I really know about RRMS and my own symtoms and whether I really am on the best medication?

  2. Vivian says:

    Just began Glatopa 20mg, everyday self injection in June. My Insurance would NOT pay for the non generic, Copaxone which is only three injections per week. I am excited that this new generic which is marketed and managed by Pfizer for US MS folk, will be approved soon as at 40mg per syringe, of Synthon’s generic would be an injection three days per week.

    Jazz, was on Rebif 44mg, 3x per week for close to four years and damn near killed me. Interferon is harsh and dangerous and Neurologist(since has been fired) should have taken me off of it per FDA, only should be used for 2 years MAX. Have a new Neurologist, old school, smart, experienced, not “in bed” with Big Pharma who prescribed Copaxone and hence, Glatopa, generic of Copaxone by Pharma Teva. Am doing well, better on Glatopa, still have symptoms but am NOT wiped out daily or have habitual infections as when on Rebif.

  3. Jaz says:

    Thank you Vivian, you have put my mind at ease with your reply. I live in the UK (West of Scotland), after your reply, I checked exactly what my medication is, turns out it is exactly what you are now prescribed, I was diagnosed 3 years ago, the Glatopa taken 3 times per week (is my third medication trial, the first two were not suitable, poor side effects) is really good for me, I do feel very tired after injection, but wait until bedtime and generally wake up fine in the morning, hope it continues to be good for you. Regards Jaz.

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