Teva Pharmaceutical Industries Ltd.'s crown jewel, the Copaxone multiple sclerosis treatment, is facing more generic competition — this time, in Europe.
Privately held Synthon and Alvogen secured European marketing approval for a generic version of Copaxone. The approval was granted for glatiramer acetate injection in 40 milligrams/milliliters.
The latest generic was approved using what is known as a decentralized procedure, in which companies pursue approval outside the European Medicines Agency's review process.
Mylan NV is partnered with Synthon and has exclusive distribution and supply rights for the products in several key European markets.
Alvogen is already marketing a once-daily subcutaneous 20-milligram/milliliter prefilled syringe under the brand name Remurel. Synthon and Alvogen work as partners in selling the product.
Teva's Copaxone delivered sales of more than €505 million in Europe in 2016, according to IMS Midas data.
The U.S. Food and Drug Administration also recently approved the injection in 40-milligram/milliliter and 20-milligram/milliliter doses.