"We will make the development of biosimilars (biological drug copies) as efficient as possible, so more products can be developed. I believe this is beneficial for public health."
Sarah Yim, Director General of the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, noted on the 4th at the Global Bio Conference (GBC 2025) hosted by the Ministry of Food and Drug Safety at the Grand InterContinental Parnas in Gangnam, Seoul, that "the approval process for the development of biosimilar antibody therapeutics will be streamlined."
Director General Yim also serves as the chairperson of the biosimilars working group of the International Pharmaceutical Regulators Forum (IPRF), which was launched in January 2018. According to her announcement that day, the FDA is expected to simplify the 'Comparative Efficacy Study (CES)' required for biosimilar development.
CES is a process to evaluate whether the effects and safety of clinical efficacy of two or more treatments are similar. Director General Yim stated, "We are currently reviewing CES-related policy documents and will only require CES when there are very specific reasons," adding, "In the future, we will not simply require CES from the beginning."
A biosimilar is a copy product made to resemble an original biological drug whose patent has expired, with similar therapeutic effects and safety. However, since biosimilars are made from biological materials, it is difficult for their efficacy to match that of the original drug completely, unlike generic drugs, which are chemical syntheses. If efficacy tests are strengthened in comparative clinical trials, it becomes more challenging to develop.
The average development period for biosimilars extends from 5 to 10 years. During this time, the global biotechnology industry has faced challenges due to the demand for many patients in comparative trials and the high expenses for purchasing the original drugs for comparison.
Director General Yim explained, "This reflects the understanding that there are difficulties for biosimilars to undergo CES due to issues such as comparing with different standard drugs by region and differences in user interface."
The FDA's relaxation of biosimilar review processes is attributed to the significant benefits it provides to public health. Generally, they are launched at prices approximately 30% lower than those of original biological drugs. Supplying drugs at lower costs makes it easier for patients to benefit.
Director General Yim remarked, "While CES data can provide some degree of trust to doctors, we must avoid approval delays due to unnecessary clinical trials," and "in a reality where the development period lasts over five years and many resources are invested, we should not hinder efficient development." He added, "Moving forward, we plan to review other areas to enhance program efficiency."
Following Europe, the U.S. is also moving toward simplifying the biosimilar development and approval processes to enhance patient accessibility. In April, the European Medicines Agency (EMA) also announced a draft guideline aimed at reducing the extensive amount of clinical data required for biosimilar approvals. Europe plans to finalize the guidelines by the 30th and implement them starting in 2026.
The background behind the U.S. and Europe pursuing efficiency in biosimilar development approval processes is the perception that biosimilars help reduce the financial burden of healthcare on various countries. Some expect that this global regulatory shift will benefit domestic corporations developing and exporting biosimilars, such as Celltrion, Samsung Bioepis, and Dong-A ST. However, there are opinions that, as the development hurdles are lowered, competition among biosimilars may intensify.