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New Korean Law On Cutting-Edge Biologics Raise Hopes And Concerns

Executive Summary

A new South Korean law to support and manage the safety of cutting-edge regenerative medicines and biologics has been passed amid hopes these will become a national growth engine, although there are concerns that a further easing of rules could lead to another 'Invossa incident'.

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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.

Zolgensma, Kymriah First Korean Approvals Under New Biologics Law

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.

Invossa Approval Revoked As Korea Confirms False Data Submission

In a worst case scenario for the country’s first approved gene therapy, South Korea has cancelled the global-first approval of Kolon Life’s Invossa and asked prosecutors to press criminal charges against the company, which it concluded submitted false data to support approval. The major blow to the company comes as it is already facing lawsuits from patients and investors, and has prompted a broader regulatory overhaul for novel biologic therapies.

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