"Phase 3 trial waiver·review shortcut"…for K-biosimilar

Ministry of Food and Drug Safety (MFDS) announces the regulatory reform proposal

Items that have already been approved will be retroactively applied

AI-generated image

The competitiveness of Korean biosimilars is projected to strengthen as the Ministry of Food and Drug Safety (MFDS) pursures regulatory reform that waive the requirement to submit therapeutic confirmatory clinical trial (Phase 3) data during the marketing authorization application process for biosimilars, provided that comparability in quality and non-clinical data is demonstrated.

In addition to the 'Biosimilar Review Innovation Plan (reducing the review timeline to up to 240 days)' recently introduced by the MFDS to bolster global competitiveness, this measure is expected to create a powerful synergistic effect, significantly lowering the development burden on domestic biotech companies and accelerating their entry into global markets.

A 'Two-Way Synergy' between Phase 3 clinical trial waivers and the 240-Day review 

In the biosimilar development pipeline, Phase 3 clinical trials have been the greatest hurdle, consuming the most time and requiring astronomical costs. Under the reform plan, developers can be exempted from Phase 3 trials if they successfully demonstrate comparability to the reference product in terms of quality, non-clinical data, and pharmacokinetic (PK) profiles.

Notably, this is closely linked to the MFDS's recently announced initiative to reduce the biosimilar review timeline to up to 240 days. When promising biosimilar pipelines, already significantly truncated during the clinical trial stage, are placed on the MFDS's innovative and expedited review track, the overall commercialization cycle is projected to be advanced by several years compared to legacy timelines.

Industry experts evaluate that companies will now have a springboard to secure 'first-mover' advantages or early price competitiveness in the global market, not only by reducing clinical development costs but also by minimizing administrative review bottlenecks.

The benefits of shortened development timelines and accelerated review speeds will also translate directly to patients. As safe and effective biosimilars capable of substituting for high-cost original biologics are rapidly introduced to the market, the financial burden on patients is expected to ease significantly. It is expected to have a positive impact on safeguarding the fiscal soundness of the national health insurance fund.

Through this reform, the MFDS has cleared a path to waive not only Phase 3 clinical trials but also the submission of non-clinical 'repeated-dose toxicity study data,' provided that analytical comparability in terms of quality and pharmacological profiles with the reference product is established. Consequently, companies will be able to gain momentum starting from the early candidate validation phase, substantially accelerating overall pipeline development efficiency.

Notably, the public notice ensures that the revised regulations can be applied even to products whose marketing authorization or variation applications have already been submitted to the MFDS and are currently under review at the time of enforcement. The pharma-biotech industry is actively welcoming this 'surprise retroactive application' and the MFDS's consecutive forward-looking regulatory innovations, given that products awaiting approval could have immediate benefits.

The MFDS plans to gather opinions from institutions, organizations, and individuals through an administrative notice period ending on June 19, after which the reform plan will be finalized and enacted. Attention is focused on whether the MFDS’s comprehensive deregulation spanning the entire life cycle of development (Phase 3 waiver) and review (240-day reduction) will activate a sluggish investment market and serve as a catalyst to further solidify South Korea’s status as a global biosimilar powerhouse.