Tyruko was developed by Polpharma and will be commercialized by its collaboration partner Sandoz.
The treatment received marketing authorization in Europe as a single disease-modifying therapy (DMT) in adults with highly active relapsing remitting MS (RRMS), the same indication as approved by the EC for the reference medicine Tysabri (natalizumab).
Tyruko was developed to have the same strength and dosage form, intravenous (iv) route of administration, dosing regimen, and presentation as Tysabri.
MS is a progressive, chronic inflammatory, and neurodegenerative disease of the central nervous system, that can take a heavy toll on the lives of those affected.
MS cannot be cured, but treatments can modify the course of disease. Due to the high costs of medication, broader access to more affordable treatment options is needed to reduce the substantial economic impact of MS on healthcare systems – which is estimated to be as much as €37K to €57K per patient per year.
Polpharma Biologics has said it is focused on broadening access to biological medicines used to treat diseases across neurology, immunology, and ophthalmology.
The company is currently developing its pipeline of more than seven biosimilars in early-late-stage development.
Michael Soldan, CEO of Polpharma Biologics, said: “We are delighted that the European approval of Tyruko comes hot on the heels of approval in the U.S, meaning that millions of people living with multiple sclerosis around the world may soon have the option of a more affordable treatment for their disease. Tyruko is the second EMA and FDA-approved biosimilar produced by Polpharma Biologics and the first one developed entirely in-house. We’re building on this extensive scientific and manufacturing expertise to further advance our pipeline of other high potential biosimilar targets.”