South Korean biosimilar companies, including Celltrion, are making significant strides and gaining prominence in the global market. (Image courtesy of Yonhap)
SEOUL, July 14 (Korea Bizwire) — In a move expected to accelerate the rollout of biosimilars — often referred to as a next-generation growth engine — South Korea’s drug regulator plans to streamline the approval process for these cost-effective biologic drugs beginning in 2026.
According to pharmaceutical industry sources on Sunday, the Ministry of Food and Drug Safety (MFDS) is developing a new review and approval framework specifically for biosimilars. The initiative, currently under government review and consulting, aims to reduce time-to-market and encourage domestic production.
The proposed reform mirrors the fast-track approval system already in place for new drugs, which reduced the average review period from 420 to 295 days this year. Under the new biosimilar regime, the MFDS will assign product-specific review teams, increase face-to-face consultations, and expedite inspections related to Good Manufacturing Practices (GMP) and clinical trial standards (GCP).
This regulatory overhaul is expected to significantly increase the number of biosimilars entering the Korean market. Although 18 biosimilars were approved in 2024 — a record high — they still accounted for just 1.5% of the total 1,197 drug approvals that year.
The timing is strategic, as several original biologic drug patents are set to expire soon, opening the door for local pharmaceutical companies to file for biosimilar approvals. Faster approvals would also align with the Yoon administration’s broader healthcare agenda, which emphasizes securing essential and rare drugs as a national responsibility.
The MFDS is also considering extending the fast-track review system to other innovative pharmaceuticals, such as those that radically alter dosage forms or combine existing ingredients in new ways. This could improve access for niche patient populations, including those with digestive disorders or difficulties with oral medications.
A pharmaceutical industry representative welcomed the initiative, noting, “If the MFDS expands its review staff and applies an appropriate increase in application fees, it will speed up commercialization for technically sound products while discouraging excessive, low-quality filings that strain regulators.”
M. H. Lee (mhlee@koreabizwire.com)
