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.
Europe’s biosimilar market leads the globe in uptake and size. However, without global regulatory alignment, even the world’s most mature biosimilar market will find it challenging to close the biosimilar void. In this issue, we explore why global regulatory alignment is critical to the future of biosimilars.
Barriers to Global Biosimilar Market Entry
Europe has maintained a global leading position in biosimilars since 2006. Its market is 55% larger than that of the US, according to The Impact of Biosimilar Competition in Europe January 2026 report by IQVIA. Recent regulatory movements in Europe, such as the EU Biotech Act and EU pharmaceutical legislation, aim to improve further access.
However, the same IQVIA report notes the impact of these efforts is limited, highlighting the lack of global regulatory alignment as a primary challenge. The variation of regulatory requirements from one country to another complicates an already time-consuming and costly development process. Without alignment, significant barriers remain for biosimilar manufacturers seeking global market presence.
These barriers present a universal challenge.
What Global Regulatory Alignment Looks Like
Regulatory alignment enables greater predictability, scalability and efficiency. It can be achieved in at least three ways:
● Regulatory convergence enables one data set to be used across multiple jurisdictions.
● Regulatory reliance uses previous reviewer evaluations for more timely approvals.
● Recognizing a global comparator product avoids redundant local studies when the reference product was approved in multiple jurisdictions based on the same data.
Understanding the science behind biosimilars and their interchangeability with reference products is essential to streamlining approval processes worldwide. As regulatory frameworks steadily catch up with established science, eliminating redundant studies and shortening approval timelines will crucially increase market appeal for manufacturers.
“On the science and regulatory science, everybody’s on the same page,” says Gillian Woollett, VP and Head of Regulatory Strategy and Policy at Samsung Bioepis. “As a practical matter, getting the leading regulators working together on the same page is probably the most important first step.”
Leading regulators, like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), are driving this international discourse. A significant step was taken in mid-2025 when the International Council for Harmonisation (ICH) began discussing a “Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs.” Continuous dialogue among all stakeholders is vital to shaping these future frameworks.
Global Regulatory Approval Status
Currently, the regulatory environment for biosimilars remains unaligned. Some major markets — including Japan, China and Brazil — still mandate comparative efficacy studies (CES) as part of the biosimilar approval process as of late 2025.
However, momentum appears to be building towards international consensus. Last year, several regulators signaled openness to biosimilar-first strategies in proposals and draft documentation.
Keeping the Momentum Towards Global Consensus
As the biosimilar landscape shifts towards greater regulatory alignment, market participants should:
● Prepare for accelerated approval processes. With faster timelines across jurisdictions, manufacturers must be ready to supply at scale. Building strong global partnerships that ensure reliable supply chains and distribution channels will be critical for operational readiness.
● Continue to prioritize quality assurance and scientific evidence. Sustainable market growth depends on long-term trust. Confidence in biosimilars is built on sound science, transparency and a proven track record in quality-factors that will become even more pertinent as more biosimilars enter the market without having to conduct redundant clinical studies.
Proactive market participants who anticipate these changes will be best positioned to maximize the opportunities ahead.
For more insights into the current state of progress in biosimilar regulation, read Gillian’s editorial in the Winter 2026 edition of EBR magazine here.
