1. Pink Sheet

Zolgensma, Kymriah First Korean Approvals Under New Biologics Law

But Reimbursement Path Still Unclear

 
• By Jung Won Shin

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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Korea Debates Appropriate Reimbursement System For Cutting-Edge Biologics • Source: Alamy

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.

All eyes are now on how the products will be treated for reimbursement under the national health insurance (NHI) system as an indication of what models for other similar

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