Korea Drug Regulator Eases Biosimilar Phase 3 Rules; Kolon Names New CEO

 

South Korea’s Ministry of Food and Drug Safety said March 27 that its National Institute of Food and Drug Safety Evaluation has released guidance outlining what to consider when deciding whether a biosimilar needs a Phase 3 comparative efficacy trial. The agency also said it will run a pre-review process to support faster biosimilar development.
 

The guidance covers the theoretical basis for easing Phase 3 requirements, quality and clinical factors to weigh, and the procedures and documents needed to discuss a waiver. The ministry said it also plans to revise approval regulations to apply the eased requirements.

It includes criteria under which a Phase 3 trial may not be required when sufficient similarity and safety to an already approved original drug are demonstrated based on quality data and Phase 1 results.
 

The ministry said it will set up a pre-review system so biosimilar developers can consult on whether Phase 3 requirements can be eased for products under development.
 

Kolon Life Science said March 27 that it appointed Vice President Lee Han-kook as CEO at a shareholders meeting and board meeting held March 26.
 
Born in 1973, Lee is a pharmaceutical and biotech industry professional with experience across the full process of developing and commercializing new drugs, generics and active pharmaceutical ingredients, from R&D and manufacturing to regulatory approvals and business development at home and abroad.
 
He worked at Daewoong Pharmaceutical on synthetic research, overseas regulatory approvals, overseas business and building overseas research hubs, and later served as an executive in regulatory affairs at a biotech company in San Diego. He then moved to Kunwha Pharmaceutical, where he led the medical and R&D divisions and served as CEO.

Lee said, “Based on Kolon Life Science’s strong bio and chemical capabilities, I will build renewed trust in the global biotech market and deliver visible results.”
 
Gachon University Gil Medical Center said March 27 that it held a “heart failure public lecture” on March 25 to mark the Korean Society of Heart Failure’s Heart Failure Day. Hosted by the hospital’s Heart Failure and Pulmonary Hypertension Center, the event aimed to explain heart failure, treatment, rehabilitation and overall management in an accessible way.
 
Heart failure is a condition in which the heart’s function declines and it cannot supply enough blood. The hospital said patient numbers have steadily increased with population aging. Because early symptoms can be mistaken for simple fatigue or shortness of breath, early diagnosis and ongoing management are important.
 
The lecture was chaired by cardiology professor Shin Ik-kyun and thoracic and cardiovascular surgery professor Park Cheol-hyeon, with specialists presenting by field. A question-and-answer session followed.
   

The Jaseng Medical Foundation said March 27 that it donated 30 million won on March 26 to the child welfare organization ChildFund Korea to support a children’s spine health initiative. The donation ceremony was held in a meeting room at ChildFund Korea’s office in Seoul’s Jung District, with officials from both organizations attending.
 

The foundation said the funds will be used through September for about 600 children at 25 community child centers in the Seoul metropolitan area, including tailored stretching programs, instructor support, and providing InBody body composition tests and portable height-measuring devices. This year’s program is scheduled to run from July through September for 10 sessions, once a week.
 

The foundation said it has worked with various organizations on the project since 2011. It began with eight institutions but has expanded to 25, more than tripling in scale, to support children’s spine health. In 2017, it received an excellence award for a program at the Seoul Social Contribution Awards.

* This article has been translated by AI.

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