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Zolgensma, Kymriah First Korean Approvals Under New Biologics Law

But Reimbursement Path Still Unclear

Executive Summary

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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Cutting-Edge Biologics Approvals, Trials Pick Up In Korea After New Law

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.

New Hope, Funding Approaches As Roche Brings Evrysdi To India

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.

Japan To Reimburse Zolgensma – But At Lower Price Than US

Novartis gene therapy gets insurance coverage at record price although small patient population will limit system costs.

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