THE US Food and Drug Administration (FDA) has approved biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics.
Pharmaceutical company Sandoz's Tyruko treats all indications covered by the reference medicine, and is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis.
The FDA has also granted an orphan drug designation to Redx's zelasudil in Aug.
Zelasudil is an oral, selective rho-associated coiled-coil containing protein kinase 2 inhibitor for the potential treatment of idiopathic pulmonary fibrosis (IPF).
The FDA move will put Redx on the map as one of the key upcoming players in the treatment of IPF, though it will face intense competition, said GlobalData, an international data and analytics company.
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