The Ministry of Food and Drug Safety (MFDS) has eased Phase 3 clinical trial requirements for biosimilars, bringing South Korea’s biosimilar approval system in line with global regulatory trends led by the United States and Europe. While the burden of conducting large-scale Phase 3 trials is expected to decrease, the importance of demonstrating early-stage comparability through quality (CMC), analytical similarity, and pharmacokinetic (PK) data is expected to grow.
Industry officials said the change could reshape competition in the biosimilar market, lowering entry barriers for new players while allowing companies with extensive development experience to explore broader pipelines.
According to industry sources on July 16, the MFDS revised and implemented regulations governing the approval and review of biological products the previous day. Under the revised rules, biosimilar developers may no longer be required to submit Phase 3 clinical trial data if sufficient comparability has been demonstrated through quality assessments, nonclinical studies, and pharmacokinetic evaluations. The requirement to submit repeated-dose toxicity study data may also be waived if quality and pharmacological comparability are confirmed.
The revision reflects a global regulatory shift led by major agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which have moved to reduce unnecessary clinical trials. As a result, early comparability data is expected to play a more critical role in biosimilar development in South Korea as well.
Industry observers said the regulatory change is not simply about reducing Phase 3 trials but represents a shift in the overall approach to biosimilar development. Previously, companies invested significant time and resources into large-scale Phase 3 trials to demonstrate clinical equivalence. Going forward, approval competitiveness will depend more heavily on how precisely companies compare and analyze quality, structural, functional, and pharmacokinetic characteristics from the early stages of development.
An industry official said, “To avoid submitting Phase 3 trial data, companies will actually need to secure more sophisticated quality and analytical comparability data at the early stages. A smaller clinical trial size does not necessarily make development easier, and the ability to demonstrate early comparability will become a core competitive advantage.”
South Korean companies are also adjusting their strategies in response to global regulatory changes. Celltrion is actively utilizing the trend toward streamlined clinical trials to improve development efficiency. Recently, the company ended its European Phase 3 trial for its Keytruda biosimilar candidate CT-P51 early and voluntarily withdrew the trial application.
Celltrion said, “In line with changes in the global regulatory environment, we revised our clinical and approval strategy to reduce the number of trial participants,” adding that “there was no longer a need to maintain the trial plan after European countries were removed from the list of participating countries.”
In contrast, Samsung Bioepis is pursuing a product-specific strategy rather than applying clinical simplification uniformly across its portfolio. For its Keytruda biosimilar candidate, the company has decided to continue collecting sufficient data under its existing plan, as global clinical trials have already progressed significantly. For future pipelines, the company plans to determine whether to simplify clinical trials based on global regulatory changes and discussions with regulatory authorities.
The regulatory relaxation is expected to create new opportunities for both late entrants and established leaders. New companies may find it easier to consider entering the biosimilar market due to reduced clinical burdens, while companies with extensive development experience may gain more flexibility to pursue additional pipelines.
An industry official said, “The change could provide opportunities for both new and established players, as late entrants face lower barriers while experienced companies can expand their development portfolios. With more companies likely entering the market, competition is expected to intensify further.”