Glatopa is the first AP-rated substitutable generic designed to treat patients with relapsing-forms of multiple sclerosis (RRMS), a chronic disease of the central nervous system characterized by inflammation and neurodegeneration.
Sandoz US president Peter Goldschmidt said: "Sandoz, together with Momenta, is proud to announce the US market launch of a fully substitutable generic version of this important therapy, following FDA approval."
As part of the collaboration, Momenta will receive a $10m milestone payment upon first commercial sale and is also eligible to receive about $120m in remaining milestone payments upon the achievement of certain US commercial and sales-based milestones for the Glatopa product.
The US Food and Drug Administration (FDA) has determined Glatopa to be therapeutically equivalent to daily Copaxone 20mg, with the same active ingredients, route of administration, strength and dosage form.
Daily Copaxone 20mg, which is frequently prescribed as a first-line therapy in newly diagnosed patients, is one of the leading products marketed to treat multiple sclerosis.
The company said that Glatopa’s US-based supply chain and manufacturing process meet rigid FDA standards and is fully substitutable at the pharmacy level.