From Europe to the US... Korean Botox Accelerates Market Expansion

Hugel Botulinum Toxin 'Letibo'
Aiming to Enter 36 European Countries Next Year
US FDA Also Plans Approval Within the Year

Hugel's botulinum toxin product 'Retivo'

[Asia Economy Reporter Lee Chun-hee] Domestic botulinum toxin is accelerating market development by consecutively entering the United States, Europe, and China, which together account for 80% of the global market.

According to the pharmaceutical bio industry on the 1st, Hugel is continuing its entry into Europe based on the recommendation for approval of the botulinum toxin 'Letibo' by the Healthcare Medicines Alliance (HMA). Partnering with local medical aesthetic specialist company Croma, Hugel plans to introduce Letibo in a total of 36 European countries by next year.

Among the five major countries that account for 70% of the European market?France, the United Kingdom, Germany, Italy, and Spain?approval has been completed in France and the UK, and approvals are being obtained sequentially in Austria, Romania, Ireland, and others. In the past, approvals were granted through the European Medicines Agency (EMA), but with the change of the approval authority to HMA, separate approvals must be obtained individually from each country's regulatory agency after approval. Hugel plans to complete entry into 11 Tier 1 countries and 13 Tier 2 countries within this year and launch products in 12 Tier 3 countries next year to finalize its European expansion. Actual shipments of products destined for Europe began on the 23rd of last month.

Hugel's next target is the United States. Hugel submitted the application for Letibo's approval to the U.S. Food and Drug Administration (FDA) in March last year. However, recent consecutive setbacks of domestic new drugs pose concerns. Due to the COVID-19 pandemic, essential on-site factory inspections required in the FDA's new drug approval process were delayed, resulting in requests for additional information, and statistical significance issues in clinical trials led to failures in obtaining approval, causing repeated failures to clear the FDA hurdle.

Nonetheless, Hugel claims that Letibo has effectively overcome these issues. The FDA inspection of the Chuncheon Geodu factory, where Letibo is produced, was completed in August last year, and since the product is approved and distributed in various countries worldwide including EMA jurisdictions, there are no major obstacles.

However, due to the Prescription Drug User Fee Act (PDUFA), the FDA review completion originally scheduled for the 31st of last month and Hugel's target of first-half approval and second-half U.S. market launch are likely to be somewhat delayed. A Hugel official explained, "Auxiliary aspects related to FDA approval are somewhat delayed due to COVID-19 issues," adding, "We expect approval around mid-year." After completing preparatory work, full-scale sales in the U.S. are expected to begin next year.

As of last year, the aesthetic botulinum toxin market is estimated at about 3 trillion KRW, with the U.S., China, and Europe accounting for 80% of the market. The U.S. market is approximately 1.6 trillion KRW, China 800 billion KRW, and Europe about 500 billion KRW, with the U.S. market alone accounting for half of the total. Successfully establishing a foothold in the U.S. market means continuous revenue generation is possible.

Daewoong Pharmaceutical, which has already successfully launched the botulinum toxin 'Nabota' in the U.S., recorded its highest-ever sales last year driven by Nabota's performance. Nabota's sales last year were 79.6 billion KRW, a growth of over 55% compared to 50.4 billion KRW the previous year. Daewoong Pharmaceutical plans to continue its growth by launching Nabota in Europe and China within this year, having applied for Chinese approval last December.

Medytox is also targeting the U.S. market. It is expected to soon begin discussions with the FDA for the Biologics License Application (BLA) after completing the analysis of Phase 3 clinical data for the liquid botulinum toxin 'MT10109L,' which was returned from AbbVie.

This content was produced with the assistance of AI translation services.