MFDS, "Increase in fees will expedite biosimilar approval"

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 that it will shorten the approval period from the current 406 days to 295 days.

 

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.

 

An MFDS official stated on September 16 to a group of specialized journalists, "Similar to our innovative plan for new drug approvals, we will expand customized consultations through the operation of a dedicated review team." The MFDS plans to establish a dedicated review team (10-15 reviewers) from various fields to conduct biosimilar reviews in areas such as ▲safety and efficacy ▲quality management ▲Good Manufacturing Practice (GMP) ▲Good Clinical Practice (GCP).

 

Specifically, the teams will be organized by product, centered around the Biopharmaceutical Policy Division's 'Bio Approval TF' within the Biopharmaceuticals and Herbal Medicines Bureau.

 

An official from the Bio Approval TF said, "We have received positive feedback from the industry since implementing the innovative plan for new drug approvals in January," and added, "The dedicated teams will be structured similarly to the new drug innovation plan and are expected to provide swift and accurate approval reviews for biosimilar products." The MFDS also announced plans to prioritize GMP inspections for biosimilar products.

 

The core of this initiative is to conduct GMP evaluations and on-site inspections within 90 days of submitting the approval application.

 

The agency also plans to recruit highly qualified reviewers.

 

Another MFDS official stated, "This matter has not yet been finalized, so I must be cautious in expressing an opinion," and added, "If the biosimilar approval fee increase is finalized, we plan to supplement our staff with highly qualified reviewers to enhance our approval and review capabilities, thereby improving patient access to treatment in Korea.

 

We will do our utmost to respond to the growing demand for biosimilar products." The industry believes that if GMP inspections are completed within 90 days, the approval speed could increase even further.

 

An industry official said, "The demand for biosimilar products has been increasing recently due to the rise in chronic diseases and the aging population," and added, "Because of this, pharmaceutical companies are seriously beginning the development and approval applications for biosimilar products.

 

If the fee increase becomes a reality, the shortened approval timeline will likely accelerate product launches." According to the '2024 Drug Approval Report' released by the MFDS, biosimilar products (equivalent biological medicines) recorded a total of 18 items (10 APIs), an increase of 6 items from the previous year, marking the highest number of approvals since the first product approval in 2012.

 

More than half of these (13 items, 7 APIs) were domestically developed in Korea, suggesting that the domestic biosimilar industry, led by Celltrion and Samsung Biologics, has gained global competitiveness.