The immune cancer treatment "Keytruda," which ranks first in overall pharmaceutical sales, the rheumatoid arthritis drug "Humira," which had been the top seller for a decade since its launch, and the recently in-demand obesity drug "Wegovy" are all biopharmaceuticals made from substances derived from humans or other organisms. They have fewer side effects and better therapeutic effects compared to traditionally synthesized medicines (synthetic drugs), leading to their increasing market share.
According to the "2024 Biopharmaceutical Industry Trend Report" by the Korean Biopharmaceutical Association, the global biopharmaceutical market is projected to grow at an annual average of 9%, increasing from 663 trillion won in 2023 to 1,114 trillion won by 2029. The domestic biopharmaceutical market is also growing, with the production of biologics, including biosimilars, entering the 2 trillion won range for the first time in history. Biopharmaceuticals include genetically recombinant medicines, cell and gene therapies (CGT), cell culture medicines, and vaccines.
The government is also taking steps to promote biopharmaceuticals. The Korea Drug Administration, under the Ministry of Food and Drug Safety, held a "2025 Biopharmaceutical Licensing and Review Capability Enhancement Seminar" on the 17th at the ST Center in Gangnam, Seoul, targeting industry stakeholders, and announced its work plan for this year, including guidelines development.
Choi Young-joo, head of the Biopharmaceutical Review Department, noted, "We have started discussions for listing the World Health Organization (WHO) as a recognized regulatory authority for medicines and for joint evaluations with the European Medicines Agency (EMA)," and added, "We will actively support domestic pharmaceutical companies and research institutions to facilitate clinical entry and the approval of domestically produced biopharmaceuticals."
In particular, for genetically recombinant medicines, there are plans to standardize review criteria that are in line with global standards to support the development and approval of biosimilars. By November, guidelines regarding the information format for demonstrating equivalence with original medicines will be provided. The evaluation agency is also creating new international pharmaceutical regulation harmonization guidelines (ICH) for the simplification of biosimilar clinical trials in collaboration with the U.S. Food and Drug Administration (FDA).
The review process for antibody-drug conjugates (ADC), which have been actively developed worldwide, will also be reformed. Guidelines for quality evaluation of ADC candidate substances will be established for the first time globally by November. ADCs are the latest targeted therapeutic drugs known as guided missile cancer treatments that deliver drugs solely to cancer cells.
The evaluation agency also plans to revise regulatory guidelines in the CGT field, including CAR-T (Chimeric Antigen Receptor T-cell) therapies, gene editing technologies (CRISPR-Cas9), and stem cell therapies. In June of this year, guidelines for immune toxicity evaluation of allogeneic stem cell therapies will be established, and in October, considerations for evaluating dendritic cell therapies for cancer treatment and guidelines for quality control testing items of cell therapies will be released.
In the case of vaccines, guidelines for evaluating diphtheria, tetanus, and pertussis combination vaccine (Tdap) are planned to be revised by June. The plan includes incorporating detailed information, including consistency verification in validation of manufacturing/testing methods to apply a single dilution method. The Tdap vaccine is classified as a nationally required vaccination, but all vaccines distributed domestically rely entirely on imports. GC Biopharma is currently conducting Phase 1 and 2 trials.
Last month, a public-private consultative body for joint reviews (OPEN) was formed, and quarterly meetings will begin this month. A vaccine clinical support consultative body will also be operated by the end of the year. For items entering clinical trials among the corporations developing the first vaccine platform in the country, technical support, including step-by-step clinical design, will be provided.