The Ministery of Food and Drug Safety, together with the World Health Organization (WHO), will work to strengthen biosimilar (biosimilar) regulatory capacity in the Asia-Pacific region.
The National Institute of Food and Drug Safety Evaluation (NIFDS) under the Ministery of Food and Drug Safety said it will co-host a "biosimilar evaluation guideline implementation workshop" with WHO for three days from the 24th to the 26th of this month.
The workshop, under the theme of "promoting biosimilar regulatory harmonization," will first be held in Korea. About 40 participants, including major overseas regulatory agencies such as the National Medical Products Administration of China, the Food and Drug Administration of the Philippines, and the Department of Health of Hong Kong, WHO officials, and domestic and international biosimilar experts, will attend to promote implementation of the WHO biosimilar evaluation guideline and discuss ways to harmonize regulations.
Key programs include: ▲ lectures by international experts on the core content of the WHO biosimilar evaluation guideline ▲ group discussions on implementation cases for monoclonal antibody biosimilars ▲ intensive discussions to narrow perspective gaps between regulators and industry.
The Ministery of Food and Drug Safety was designated a "WHO collaborating center for standardization and evaluation of biopharmaceuticals" in 2011. Since then, it has taken part in establishing and revising WHO regulatory guidance and has held workshops to support implementation of regulatory guidance in the Asia-Pacific region.
In particular, it played a leading cooperative role in the establishment (2010) and revision (2022) of the WHO biosimilar evaluation guideline, and in 2009 published the "quality evaluation guideline for similar biotherapeutic products." In 2012, it also achieved the world's first approval of an antibody biosimilar.
Through this workshop, the Ministery of Food and Drug Safety expects to enhance mutual understanding between national regulators and industry experts and to strengthen review expertise through biosimilar regulatory harmonization in the Asia-Pacific region.
An official at the Ministery of Food and Drug Safety said, "We plan to continue strengthening cooperation with WHO to lead international regulatory harmonization and establish a regulatory foundation that can support overseas expansion of domestic biopharmaceuticals."