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  • MFDS, "Increase in fees will expedite biosimilar approval"
  • by Lee, Tak-Sun | translator Hong, Ji Yeon | Sep 18, 2025 06:02am
A dedicated review team will be available, and GMP review will be prioritized¡¦plans to recruit highly qualified reviewers
The Ministry of Food and Drug Safety (MFDS) has announced that it will expedite biosimilar approvals in relation to a recent "increase in approval fees."

The MFDS plans to establish a dedicated review team to provide approval and review services commensurate with the new fees.

The MFDS issued an administrative announcement on September 12 regarding a partial amendment to the 'Regulations on Fees for Pharmaceutical Approvals, etc.', which primarily details the reorganization of approval fees for biosimilars (biological medicines).

According to the amendment, the approval fee for biosimilars will increase to KRW 310 million, a significant jump from the previous KRW 8.031 million.

Also, the MFDS announced t
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