The approval review capacity for biosimilars is expected to be strengthened, shortening the approval period from the current 406 days to 295 days.

Biosimilars are biological products that have demonstrated quality and non-clinical/clinical comparative equivalence to products already approved for manufacturing, sale, or import.

To this end, the Ministry of Food and Drug Safety (MFDS) issued an administrative notice on Thursday regarding a partial amendment to the “Regulations on Fees for the Approval of Drugs,” primarily focusing on revising fees for biosimilar product approvals.

This administrative notice is one of the follow-up measures taken after the interagency “Bio Innovation Forum” held last Friday. It aims to significantly reduce approval periods by applying the approval innovation measures, including fee revisions for new drugs, to the approval of biosimilars, the ministry said.

According to the amendment, the product license fee for biosimilar drugs will be recalculated to 310 million won ($223,310). The MFDS plans to utilize the resulting funds to establish dedicated review teams and hire highly competent reviewers, including physicians and pharmacists. By strengthening review capabilities, the ministry aims to reduce the approval period for biosimilar drugs from the current 406 days to 295 days.

To alleviate the burden on the industry, a 50-percent reduction in fees will be applied when small- and medium-sized enterprises apply for approval of domestically developed biosimilars. Furthermore, if the same applicant submits applications for multiple products with the same active ingredient but different concentrations, the fee for the second and subsequent items will be reduced to 8 million won (based on electronic application standards).

“Following last year's adjustment of new drug approval fees to reflect actual costs, we expect this reassessment of biosimilar fees will strengthen the support system for rapidly growing biopharmaceuticals, accelerating their entry into overseas markets,” the ministry said.