Novartis AG’s Zolgensma (onasemnogene abeparvovec) and Kymriah (tisagenlecleucel) have become the first drugs to be approved in South Korea under a new law governing novel regenerative medicines and biologics implemented last August.
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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