Korea pairs a 200-company bio push with faster drug approvals

South Korea's biotech policy is moving on two fronts in the same week: money and prestige for selected companies, and lower regulatory walls for the products they want to sell. On Oct. 29, the Ministry of Health and Welfare and the Ministry of SMEs and Startups said they would jointly pick 50 small and venture pharmaceutical and biotech companies a year, 200 by 2030, and support each for up to five years.

The case for the programme is a widening gap. The domestic pharmaceutical and biotech market grew from 23.2 trillion won ($17.4 billion) in 2020 to 31.7 trillion won ($23.7 billion) in 2024. Over roughly the same period, the number of biotech ventures founded fell from 581 in 2020 to 288 in 2023.

The 50 annual picks are split across drug development, medical devices and digital health, and biomaterials and production technology. Each company is matched with a growth director and gets two years of tailored support, with better performers eligible for three more years. A bank dedicated to research and development is to put in 60 billion won ($44.9 million) over three years, alongside 90 billion won ($67.4 million) in commercialisation guarantees.

The same week, the Ministry of Food and Drug Safety published a revised guideline for biosimilars, the copies of biological drugs. It allows frozen reference products to be used in analysis and lets companies compare against earlier results rather than run every test side by side. Where quality, non-clinical and pharmacokinetic comparability are shown, the guideline waives the Phase 3 confirmatory trial, following a July revision of the licensing regulation.

The regulator also began on Oct. 30 a one-stop review for digital convergence medicines, products that combine a drug with a digital medical device or health device. A joint team of drug, biological and device reviewers handles each application.

At the health ministry, a regulation issued on the same day reclassified cultured autoimmune cell therapy as low-risk. Researchers can now apply to run a treatment plan on the strength of published literature instead of going through a preliminary clinical study that the ministry said takes two to three years. The ministry said such therapy had been classed as medium-risk despite comparatively established safety, and that patients needing cell treatment after cancer care had faced years of waiting at home and heavy costs abroad.

The literature route is tightly drawn. Cells used must match those in the studies, the treatment plan must match on disease and patient group, purpose and route of administration, and the papers must come from peer-reviewed international journals, with a search strategy submitted.

For the 200 companies, much depends on what follows selection. The ministries say they will run a joint council to collect regulatory complaints and take them to the relevant agencies.