Hugel's 'Botulax' Obtains Spanish Product Approval... Approval Completed in 11 Major European Countries

[Asia Economy Reporter Lee Gwan-joo] Hugel announced on the 8th that it has obtained marketing authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) for its botulinum toxin product 'Botulax (export name Retivo)' 50 units (Unit) for the indication of glabellar wrinkles.

With Spain as the last, Hugel has completed obtaining marketing authorizations in the 11 major European countries originally targeted. Spain, along with the previously approved UK, France, Germany, and Italy, is one of the Big 5 countries that account for 70% of the European botulinum toxin market, showing the steepest growth with an average annual growth rate of 13%. The market size is expected to expand from approximately 50 billion KRW this year to 70 billion KRW by 2025.

A Hugel official said, “Since Spain regards product quality as the most important criterion for brand selection, Botulax, the 'No.1 product in Korea,' will accelerate market entry based on its safety and stable efficacy,” adding, “We will also make every effort to obtain marketing authorizations and launch in the remaining European countries, aiming to enter 36 European countries by 2023.”

In January this year, Hugel received a recommendation for marketing authorization for Botulax 50 units from the Heads of Medicines Agencies (HMA) in Europe. Subsequently, in March, Hugel launched its botulinum toxin product in Europe for the first time among domestic companies with the first shipment to France and Austria, along with participation in local academic conferences and exhibitions.

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