Biosimilar Approval Period to Be Shortened, Fees to Be Increased

MFDS Announces Administrative Notice of Amendment to Pharmaceutical Approval Fee Regulations

The Ministry of Food and Drug Safety announced on September 11 an administrative notice of a partial amendment to the "Regulations on Fees for Approval of Pharmaceuticals, etc.," with the main focus on revising the approval fees for biosimilars.

This administrative notice is one of the follow-up measures to the joint "Bio-Innovation Forum" held by government ministries on September 5. The aim is to apply approval innovation measures, such as the revision of new drug approval fees, to biosimilar approvals as well, in order to significantly reduce the approval period.

Biosimilars refer to biological products whose quality and non-clinical and clinical comparability have been demonstrated to be equivalent to those of products that have already been granted manufacturing, sales, or import approval.

According to the revised regulation, the approval fee for biosimilars will be recalculated from the current 8,031,000 won to 310 million won. To ease the burden on the industry, the Ministry will reduce the fee by 50% for biosimilars developed domestically by small and medium-sized enterprises. In addition, if the same applicant applies for similar approvals, the fee for the second and subsequent products will be reduced to 8 million won (based on electronic applications).

The Ministry plans to use the increased fee revenue to strengthen review capabilities by operating dedicated review teams and hiring highly qualified reviewers such as doctors and pharmacists. As a result, the current biosimilar approval period of 406 days will be reduced to 295 days starting next year.

The Ministry of Food and Drug Safety stated, "Following last year's adjustment of new drug approval fees, this recalculation of biosimilar fees will further strengthen the support system for the rapidly growing biopharmaceutical sector, thereby accelerating entry into overseas markets."

The details of the amendment can be found on the Ministry's website, and those wishing to submit opinions may do so to the Ministry by November 11.

This content was produced with the assistance of AI translation services.