바이오의약품 접근성 확대 방안

Measures to Expand Access to Biopharmaceuticals: Focusing on European and North American Cases

Backgrounds: Biopharmaceutical market is the fastest growing market in the pharmaceutical industry. However, since better drugs are sold at higher price, these drugs are less accessible by the patient population. Methods: For this study, literatures from 2018 to 2023 were searched. Pubmed (MEDLINE), Web of Science Core Collection, and Google scholar were selected for electronic databases. As a keyword ('biosimilar' OR 'biosimilars') AND ('regulatory' OR 'guideline'', 'ICH' OR 'FDA' OR 'EMA') were used, and the search was conducted by specifying that the key words should be included in the title and abstract. Result: Efforts of regulators such as EMA(European Medicines Agency) and FDA (U.S. Food and Drug Administration) - reducing approval requirements by omitting animal testing and clinical trials and promoting market penetration of biosimilars - are needed to expand market entry of biopharmaceuticals. Furthermore, expanding the indication of biosimilars through extrapolation and approving biosimilars' substitution and switching can also improve accessibility of biopharmaceuticals. Lastly, the expansion of biosimilar awareness and the prevention of illegal transactions will also contribute to the improvement of accessibility of biopharmaceuticals. Conclusion: The significance of this study is that it examines how the use of biosimilars can be promoted and ultimately the accessibility of biopharmaceuticals can be expanded, focusing on specific cases in Europe and the United States.