The delayed approval and price setting of Novartis Pharma’s Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy (SMA) listed in May, has raised questions about how the sakigake designation system should be operated. Despite being designated for the…
REGULATORY
MHLW Proposes Earlier Price Cuts for Off-Patent Drugs with 80%-Plus Gx Rates, but Chuikyo Questions 2-Year Grace Period
The Ministry of Health, Labor and Welfare (MHLW) on November 22 tendered a proposal to shorten the current price reduction timeline for off-patent branded drugs called long-listed products (LLPs) if their generic replacement rates reach 80%. However, a two-year grace…
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