The European Medicines Agency (EMA) is poised to introduce a new guideline aimed at establishing more robust comparative data to support therapeutic equivalence (TE) for nasal products to address gaps in the current framework.
Therapeutic equivalence refers to the concept where two drugs or drug products are considered interchangeable if they are expected to have the same clinical effect and safety profile when administered to patients under the same conditions. In the context of nasal products, therapeutic equivalence implies that different formulations or brands of nasal medications should provide comparable therapeutic outcomes.
For nasal products, which include nasal sprays and inhalers for various conditions such as allergies, congestion, and nasal infections, establishing therapeutic equivalence can be particularly challenging. These products are delivered directly to the nasal mucosa, which can be sensitive and variable among individuals. As a result, ensuring consistent efficacy and safety across different products is crucial.
The proposed EMA guideline addresses several key issues associated with nasal products, including variability of performance, complexity of drug delivery, and patient safety and efficacy, and is expected to be similar in format to the current guidelines for TE in orally inhaled products, such as those for the treatment of chronic obstructive pulmonary disease (COPD) and asthma The EMA’s Rheumatology and Immunological Working Party is releasing the guideline with a three-month consultation period.
Public comments are being accepted until October 31, 2024 here.
Read the full concept paper here.
