Hugel's 'Botulax' Recommended for Approval of European HMA Marketing Authorization

Hugel CI (Photo by Hugel)

[Asia Economy Reporter Chunhee Lee] Hugel's botulinum toxin 'Botulax (export name Letibo)' is entering Europe.

On the 26th, Hugel announced that on the 25th (local time), it received a recommendation for marketing authorization approval for Letibo, a botulinum toxin indicated for glabellar lines, from the Heads of Medicines Agencies (HMA) in Europe.

The HMA is an alliance of medicines regulatory agencies from various European countries. During the approval process for European market entry, a Reference Member State (RMA) leads the procedure. In this case, the German Federal Institute for Drugs and Medical Devices (BfARM) led the review and issued the recommendation for approval of Letibo.

Based on this decision, Hugel plans to submit marketing authorization applications for Letibo to national medicines agencies starting early next month, targeting the five major European countries that account for 70% of the European market (United Kingdom, Germany, Italy, France, Spain), as well as 11 other European countries currently undergoing approval and other nations. The first shipment to Europe is expected within the first quarter following individual country approvals.

Previously, Hugel submitted marketing authorization applications for 11 European countries in June 2020. In November last year, Hugel obtained EU-GMP certification for its botulinum toxin manufacturing facility, the 'Geodu Plant,' marking the final stage of its European market entry.

Currently, the European botulinum toxin market is one of the world's top three markets, along with the United States and China, accounting for about 80% of the global botulinum toxin market. The market size is estimated at approximately 500 billion KRW. With the continuous influx of new consumers across various age groups and male consumers, in addition to traditional channels such as hospitals and clinics, treatment channels are diversifying, and the market is expected to maintain an average annual growth rate in the double digits through 2025.

A Hugel representative stated, “Botulax has proven once again its excellence and global growth potential as Korea's leading botulinum toxin product, holding the number one market share domestically for six consecutive years. Based on the successful experiences accumulated in domestic and international markets, we will do our best to quickly establish a foothold in the European market and contribute to enhancing the status of Korea's pharmaceutical and bio industries.”