The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea and the World Health Organization (WHO) have brought together medicines regulators from across the Western Pacific Region to support implementation of the revised WHO Guidelines on Evaluation of Biosimilars, part of ongoing efforts to help more patients access affordable and quality treatment.
Biotherapeutic medicines have transformed treatment for many people living with cancer, autoimmune diseases and diabetes. However, their high cost keeps them out of reach for many patients, especially in low- and middle-income settings. Biosimilars are biotherapeutic medicines that are highly similar to an already authorized reference biotherapeutic product, with no clinically meaningful differences in quality, safety or efficacy.
Once patents of original biotherapeutic products expire, biosimilars can enter the market as alternatives. This can help more people access the long-term treatment these chronic conditions require.
“WHO supports stronger regulatory capacity for assessing biosimilars as they provide more affordable treatment options for people with chronic and life-threatening conditions, improving their health outcomes. At the health system level, biosimilars can also increase market competition, enabling governments to procure biotherapeutic medicines more cost-effectively, generate potential savings, and use limited public health resources more efficiently. We thank the Government of the Republic of Korea for their support in this important work,” said Lluis Vinyals Torres, Director for Division of Health Systems and Services at the WHO Regional Office for the Western Pacific.
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Dr Jinho Shin, Medical Officer at the WHO Regional Office for the Western Pacific, facilitates a discussion on evaluating biosimilars with workshop participants. © MFDS
WHO and MFDS co-hosted the Joint Workshop on Implementation of the Revised WHO Guidelines on Evaluation of Biosimilars, held in Seoul from 24 to 26 August 2026. The workshop provided National Regulatory Authorities (NRAs) with an opportunity to examine the latest scientific and regulatory approaches to evaluating biosimilars and to share practical experience from different regulatory settings. It also contributed to broader technical assistance efforts to support the implementation of WHO regulatory guidelines.
Regulators from 11 Member States participated: Brunei Darussalam, Cambodia, China (including Hong Kong SAR), Fiji, Indonesia, Lao People’s Democratic Republic, Malaysia, Mongolia, Papua New Guinea, the Republic of Korea, and Viet Nam. They were joined by regulatory experts from three WHO regions (Western Pacific, Europe, and the Americas), and representatives from manufacturing associations.
A shift in how biosimilars are evaluated
In 2022, WHO published its revised Guidelines on Evaluation of Biosimilars to reflect advances in scientific knowledge, analytical technologies and regulatory experience gained since the first WHO biosimilar guidelines were adopted in 2009.
The revised guidelines reflect a shift away from a traditional sequential approach where laboratory, preclinical and clinical studies were routinely required for every biosimilar. WHO advises a shift toward a tailored and risk-based approach that allows additional studies to be conducted when needed to address remaining uncertainties.
Supporting implementation in countries
National regulatory authorities across the Western Pacific Region vary in experience, technical capacity and regulatory frameworks for biosimilars. This highlights the need for different levels of support based on a country’s context and available resources.
Participants also identified regulatory reliance and regional cooperation as important ways to improve regulatory efficiency, particularly for authorities with limited resources or small market size. Sharing regulatory experience, information and opportunities for joint assessment can help strengthen technical capacity of NRAs in evaluating biosimilars.
“As a WHO Collaborating Centre, the Ministry of Food and Drug Safety, Republic of Korea has been working closely with the international community to promote the integration of WHO guidance into regulatory practice. This workshop constitutes part of such efforts. Thus, it is our great delight to convene this occasion here in Seoul, Republic of Korea,” said Dr Seog Yeon Kang, Director-General, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Republic of Korea.
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WHO experts engage workshop participants from 11 countries in identifying practical actions on regulatory systems strengthening. © MFDS
The workshop identified practical actions that can help countries translate the revised WHO guidelines into national regulatory practice.
Priorities include developing or aligning national biosimilar requirements with the revised WHO guidelines, developing practical assessment tools, and continuing hands-on regulatory training, including context-specific cases.
“WHO will continue to support countries in strengthening biosimilar regulation through practical guidance, capacity building, regulatory reliance and cooperation. The goal is to make regulatory decisions more efficient and evidence-based, while maintaining standards for quality, safety and efficacy and increasing access to biosimilar medicines,” said Dr Ivana Knezevic, Secretary of the Expert Committee on Biological Standardization and WHO’s Team Lead for Biologicals Norms and Standards and Transplantation.
Note for editors:
The WHO Guidelines on Evaluation of Biosimilars provide globally applicable principles for the evaluation of biosimilar biological products. The revised guideline is published in WHO Technical Report Series No. 1043 and reflects advances in scientific knowledge, analytical technologies and international regulatory experience.
A biosimilar is a biological product that is shown to be highly similar in terms of its quality, safety and efficacy to an already licensed reference product. WHO develops international norms and standards for the quality, safety and efficacy of medical products and supports Member States in strengthening national regulatory systems.
The Ministry of Food and Drug Safety of the Republic of Korea is the national regulatory authority responsible for regulating medicines, biological products, medical devices, food and other regulated products in the Republic of Korea. National Institute of Food and Drug Safety Evaluation, an affiliate institute of Ministry of Food and Drug Safety, has been designated as WHO Collaborating Center for Biological Standardization and Evaluation since 2011. MFDS provided outstanding financial, technical, and logistical support for the workshop, while also extending exceptional hospitality to participants throughout the event. Their longstanding commitment to advancing biosimilar regulation and development contributed significantly to the workshop’s success.
For more information, or to arrange media interviews, contact:
WHO Regional Office for the Western Pacific: wprocom@who.int
Ministry of Food and Drug Safety, Republic of Korea: whocc.mfds@korea.kr