The immune-oncology drug "Keytruda," which ranks first in total pharmaceutical sales, the arthritis treatment "Humira," which was the top seller for 10 years after its release, and the recently popular obesity medication "Wegovy" are all biopharmaceuticals made from substances derived from humans or other organisms. They are gaining a larger share in the pharmaceutical market recently, as they have fewer side effects and better therapeutic effects than traditional synthetic drugs.
According to the "2024 Bio-Pharmaceutical Industry Trend Report" by the Korea Bio Association, the global biopharmaceutical market is expected to grow at an annual rate of 9%, reaching 1,114 trillion won in 2029, up from 663 trillion won in 2023. The domestic biopharmaceutical market is also growing, as the production of gene-recombinant drugs, including biosimilars, has entered the 2 trillion won range for the first time in history. Biopharmaceuticals include gene-recombinant drugs, cell and gene therapies (CGT), cell culture drugs, and vaccines.
The government has also stepped in to promote biopharmaceuticals. On the 17th, the Ministry of Food and Drug Safety's Korea Drug Safety Evaluation Institute held a "2025 Biopharmaceutical Licensing and Review Capacity Strengthening Symposium" for industry representatives at the ST Center in Gangnam, Seoul, where it announced this year's work plan, including the establishment of guidelines.
Choi Young-joo, head of the Bio-Pharmaceutical Review Department, noted, "We have started discussions for registration with the World Health Organization (WHO) as a regulatory authority for medicines, as well as joint evaluations with the European Medicines Agency (EMA). We will actively support local pharmaceutical companies and research institutions to facilitate their clinical entry and obtain licenses for domestically produced biopharmaceuticals."
First, for gene-recombinant drugs, we plan to standardize review criteria that meet global standards to support the development and approval of biosimilars. By November, we will provide guidance on information registration formats related to proving equivalence with original drugs. The evaluation institute is also creating new guidelines in collaboration with the U.S. Food and Drug Administration (FDA) to simplify biosimilar clinical trials through the International Conference on Harmonization (ICH).
The review procedures for antibody-drug conjugates (ADC), which are actively being developed worldwide, will also be reformed. In November, we plan to create guidelines for quality evaluation of ADC candidates for the first time in the world. ADCs are the latest targeted therapies known as guided missile chemotherapy drugs that deliver drugs specifically to cancer cells.
The evaluation institute will also revise regulatory guidelines in the CGT field for CAR-T (chimeric antigen receptor T cell) therapies, gene-editing technologies (CRISPR-Cas9), and stem cell therapies. In June of this year, guidelines for immunotoxicity assessments of allogeneic stem cell therapies will be created, and in October, considerations for evaluating dendritic cell therapies in cancer treatments and quality control testing guidelines for cell therapies will be made public.
For vaccines, guidelines for evaluating the diphtheria-tetanus-pertussis combined vaccine (Tdap) will be revised in June. The plan is to incorporate detailed information, including consistency verification, in the manufacturing and testing method validation for applying a single dilution method. Although the Tdap vaccine is classified as a nationally required vaccination, the vaccines distributed domestically rely entirely on imports. Currently, GC Biopharma is conducting phases 1 and 2 of clinical trials.
Last month, a public-private consultative body was formed for joint reviews (OPEN), and quarterly meetings will commence this month. There are also plans to operate a clinical support consultative body for vaccines within this year. For items that have entered clinical trials among companies developing the first vaccine platform in the country, technical support, including staged clinical design, will be provided.