Food and drug safety ministry to co-host WHO biosimilar workshop

The food and drug safety ministry said it will co-host a three-day workshop with the World Health Organization from Aug. 24 to 26 to implement biosimilar assessment guidelines across Asia-Pacific.

The workshop will seek to promote regulatory harmonization for biosimilars.

About 40 overseas regulators, WHO officials and Korean and international biosimilar specialists will attend, including representatives of China's National Medical Products Administration, the Philippine Food and Drug Administration and Hong Kong's Department of Health. The program includes lectures on WHO biosimilar assessment guidance, group discussions of implementation cases involving monoclonal-antibody biosimilars and talks intended to narrow differences in perspectives between regulators and industry.

The ministry said it expects the gathering to broaden mutual understanding among national regulators and industry experts and improve review expertise through biosimilar regulatory harmonization across the region. It said it will continue working with WHO on international regulatory harmonization and support overseas expansion by South Korea's biopharmaceutical industry.

The ministry said it has worked with WHO on the biosimilar guidance, which was first issued in 2010 and revised in 2022. It also published its own quality-evaluation guideline for biosimilars in 2009 and led the world's first approval of an antibody biosimilar in 2012.