에피스 스토리
에피스 스토리
영문으로 운영되고 있는 삼성바이오에피스 SNS에 포스팅된 글입니다.
Welcome back to Re:Access, a newsletter series by Samsung Bioepis that Rethinks biosimilars as the answer to future healthcare Access.
The first biosimilars were introduced to market two decades ago, sparking a virtuous cycle that continues to bring cost savings to healthcare systems today. But the launch of biosimilars may not have been possible without comparability being introduced nearly a decade prior. Here, we unpack the relevance of a 30-year-old principle to modern biopharmaceutical development.
Revolutionizing Biopharmaceutical Regulation
On April 26, 1996, the U.S. Food and Drug Administration introduced its landmark guidance Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products.
Comparability established that a biologic could be approved after a manufacturing process change, based on evidence that demonstrates it remains highly similar or comparable to the product before such changes. The evidence views its critical quality attributes, such as structure or impurities, which means the same clinical performance can be expected.
Crucially, this meant manufacturers did not always need to repeat extensive clinical trials after manufacturing changes to confirm safety and efficacy, except in higher-risk cases.
By allowing decisions to be based on scientific evidence rather than repeated testing, comparability did not only change how existing biologics are managed. It also created the foundation for an entirely new category of medicines.
Laying the Groundwork for Biosimilars
Comparability introduced a new way to demonstrate similarity without repeating full clinical trials, laying the basis for biosimilar development approach.
Based on analytical and clinical data, the FDA determines a biosimilar to be highly similar to an FDA-approved reference product with no clinically meaningful differences in safety, purity and efficacy.
This helps remove redundant steps from costly and time-consuming development processes and expand access to biologic medicines worldwide.
Source: Biosimilars Info Sheet, Level 1: Foundational Concepts (FDA)
Trends in Regulatory Science Sparked by Comparability
Today, the impact of comparability extends beyond the development of biosimilars. Even after 30 years, the principle still continues to shape how regulators approach evidence and modernize biopharmaceutical development, including:
● Re-evaluating the need for comparative efficacy trials for biosimilars around the world, as covered in our March issue.
● Helping regulatory science adapt more quickly to next-generation biologics, as outlined in the FDA’s Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products draft guidance in July 2023.
● Streamlining unnecessary clinical pharmacokinetic (PK) testing when scientifically justified, as recommended by the FDA’s new draft guidance in March 2026.
● Applying the “least burdensome” approach to more product categories including biosimilars, as mentioned in the report produced in February 2026 by US Senator Bill Cassidy, M.D. (R-LA), which aims to modernize the FDA.
This approach of using the minimum amount of information necessary to adequately address a relevant regulatory issue was also encouraged in the paper “Least Burdensome: A Lighter Lift for FDA’s “Substantial Evidence” Gold Standard” co-authored by our VP and Head of Regulatory Strategy and Policy, Gillian Woollett, last year.
At Samsung Bioepis, we view comparability as both a historical milestone and an enduring principle that ensures regulatory consistency across all biologic medicines, while we continue to guide how they are developed and evaluated today. Ongoing regulatory shifts, including efforts to reduce unnecessary trials and adopt more efficient evidence frameworks, point toward science-led decision making. This enables the streamlining of development processes that remain rigorous, ultimately supporting broader and timelier patient access. We believe advancing this approach, built on three decades of evidence, will be key to realizing the full potential of biosimilars in expanding healthcare access around the world.
Read more about the FDA’s efforts towards “breaking the biosimilar bottleneck” through regulatory reform here: https://jamanetwork.com/journals/jama/fullarticle/2846432
