The US Food and Drug Administration (FDA) has approved two dosings of Mylan’s glatiramer acetate injection, a generic version of Teva Pharmaceutical Industries’ top-selling drug, Copaxone (glatiramer acetate), for treating patients with relapsing forms of multiple sclerosis (MS). The dosings are for 40 mg/mL for three-times-a-week injection and for a 20 mg/mL for once-daily injection. Copaxone had 2016 global revenues of $4.2 billion.

The approval of the 40 mg/mL formulation is significant. Teva had successfully applied a generic defense strategy for Copaxone when it launched a 40-mg/mL formulation of the product with a three-times a week dosing regime following the patent expiration of a first-generation 20-mg/mL formulation with more frequent dosing. Patents covering Copaxone 20 mg/mL expired in May 2014, and in most of the rest of the world in May 2015. The 40-mg/mL Copaxone was launched by Teva in the US in January 2014 and was approved in Europe in December 2015.

Teva’s business strategy for Copaxone relies heavily on the continued migration of a substantial percentage of Copaxone patients using daily doses (the 20-mg/mL formulation) to the 40- mg/mL, three-times-a-week version. Teva’s Copaxone 40 mg/mL version accounted for more than 85% of total Copaxone prescriptions filled in the US and more than 75% of its prescriptions filled in Europe based on QuintilesIMS data as of June 2017 and as reported by Teva. In February 2017, Teva suffered a setback when a federal district court ruling invalidated four of its patents relating to the 40-mg/mL formulation.

In response to the generic approvals for Copaxone, Teva issued a statement. “We have planned for the eventual introduction of a generic competitor to glatiramer acetate,” said Dr. Yitzhak Peterburg, Teva’s interim president and chief executive officer, in a company statement. “We remain confident in patient and physician loyalty to Teva’s Copaxone due to its recognized efficacy, safety and Intolerability profile, and we will continue to promote and support the product. As we are closing the third quarter, it is too soon to officially comment on any change to our full-year business outlook.”

Source: Mylan and Teva Pharmaceutical Industries