There are two definitions of a hybrid medicinal product (MP). Both definitions are reflected in the current EAEU legislation. Let’s see the criteria applicable to the hybrid MP.

1. Criteria of a Hybrid MP According to Decision No 78 Dated November 3, 2016

1) does not meet the definition of a generic MP;
2) or it is not possible to support its bioequivalence through bioavailability studies;
3) even if the product was modified versus the original product in:

• Active substance(s)
• Indications for use
• Dosage
• Dosage form
• Routes of administration

Source: Registration and Evaluation Rules for Medicinal Products for Human Use, approved by the Decision of the Council of the Eurasian Economic Commission No 78 of November 3, 2016 , article 19 Section II

1. Criteria of a Hybrid MP According to EAEU Decision No 85 dated November 3, 2016:

1) does not meet the definition of a generic MP;
2) it is not possible to support its bioequivalence through bioavailability studies;
3) and if the active substance(s), indications, dosage, dosage form or the route of administration of the medicinal drug differ from those of the reference drug, which requires preclinical and/or clinical study results

Source: The rules for bioequivalence studies of medicinal products, approved by the Decision of the Council of the Eurasian Economic Commission No 85 of November 3, 2016, Article.11 Section II

Generic MP is a drug with the same qualitative and quantitative composition of the active substances (active pharmaceutical substances) and the same dosage form as the reference medicinal product, and with bioequivalence to the reference medicinal product is supported by the corresponding bioavailability studies.

Reference medicinal product is a drug used as a product of comparison and is a reference for defining (standardizing) the properties of the medicinal product.

In conclusion, a hybrid medicinal product has a special regulatory status requiring close attention for providing data on preclinical and clinical studies and the overall registration dossier.

See more detailed information about specifics of marketing authorization of hybrid medicinal products in our next article.

January 17, 2023