The Ministry of Food and Drug Safety will overhaul its review system for biosimilars (biopharmaceutical generics). The core is to shorten review times in exchange for sharply raising the authorization fees charged to corporations.
According to a partial amendment to the "Regulations on fees for authorization of pharmaceuticals, etc." that the ministry gave advance notice of on the 11th, the item authorization fee will be adjusted from the current 8.03 million won to 310 million won.
This measure follows the cross-ministerial "Bio innovation forum" held on the 5th and expands the fee overhaul for new drug authorizations to biosimilars. The ministry said it will use the increased fee revenue to operate dedicated review teams and hire highly capable reviewers such as physicians and pharmacists, cutting the authorization period from the current 406 days to 295 days.
To ease the industry's burden, products developed by domestic small and midsize corporations will receive a 50% fee reduction, and when the same corporation applies for a similar authorization, the fee for the second item and onward will be reduced to 8 million won.
The ministry said, "As the biopharmaceutical market grows rapidly, we will strengthen the authorization and review support system to accelerate overseas expansion." Opinions on the amendment can be submitted to the ministry by Nov. 11.