Therapeutic Equivalence
Fixkoh Airmaster shows therapeutic equivalence to Seretide® Accuhaler® for both formulation and device characteristics1,2
The delivered dose of salmeterol xinafoate/fluticasone propionate from Fixkoh Airmaster met the Committee for Medicinal Products for Human Use (CHMP) criteria for therapeutic equivalence (similar within ±15% to originator).1
The results of in-vitro and in-vivo bioequivalence studies across all three dosage strengths proves that chosen materials were appropriate and that the developed formulation has a similar performance to the reference product (Seretide® Accuhaler®).2
EU guidance states that for generic inhalers, the resistance to airflow and the inhaled volume through the device should be comparable (±15%) to the reference device.3
References
1. Thornton & Ross Ltd. Data on file. 2021. Fixkoh 001
2. Swedish Medical Products Agency. Public Assessment Report: Scientific discussion. Sipova Airmaster. 2019. Available here. Access date: August 2023.
3. European Medicines Agency. Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary diseases (COPD) in adults and for use in the treatment of asthma in children and adolescents. 2009. Available here. Access date: August 2023.
Seretide® and Accuhaler® are registered trademarks of the GlaxoSmithKline group of companies.
UK-FIXK-42(2) | August 2023
