Zolgensma, Kymriah First Korean Approvals Under New Biologics Law
But Reimbursement Path Still Unclear
Novartis’s Zolgensma and Kymriah have became the first two drugs to be approved under new South Korean legislation for cutting-edge regenerative medicines and biologics, implemented last year. How the country deals with the reimbursement of these drugs is expected to determine the regulatory path for other ultra high-priced drugs such as gene therapies.
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Novartis among the first to benefit with approvals for Zolgensma, Kymriah, and Luxturna. The new law has also enabled its first clinical trial – a Phase Ib study by Seoul National University of a CAR-T therapy for recurrent or refractory, CD19-positive, B-cell acute lymphoblastic leukemia.
Roche’s Evrysdi debuts in India backed by a patient support program ahead of Novartis’ Zolgensma and Biogen’s Spinraza. Spotlights remains on the price tag for the SMA therapy amid hopes that novel approaches such as crowdfunding could also broaden access.
Novartis gene therapy gets insurance coverage at record price although small patient population will limit system costs.