Regulatory framework for non-biotechnological biological medicinal products in Spain

Abstract

Introduction: There are notable differences between drugs obtained by chemical synthesis and those achieved through living organisms, in terms of structural complexity, regulatory requirements, time and cost of development.

Objective: Examine the Spanish regulatory framework with respect to biological medicines obtained by non-biotechnological processes, in particular, those that have as active ingredient chondroitin sulfate sodium, enoxaparin sodium and teriparatide.

Methods: Descriptive, longitudinal and retrospective study of the data in the databases managed by the Spanish Agency for Medicines and Health Products and the Ministry of Health of Spain; fact sheets and public evaluation reports for biosimilar medicinal products, which their active substance is chondroitin sulfate sodium, enoxaparin sodium and teriparatide; legal provisions and guidelines in force from 2001 to 2021.

Results: Authorizations were requested as reference medicines for the following active ingredients: chondroitin sulfate sodium, teriparatide and enoxaparin sodium. Biosimilars for chondroitin sulfate sodium, teriparatide and enoxaparin sodium. Generics for teriparatide, and by hybrid procedure for chondroitin sulfate sodium and teriparatide.

Conclusions: Due to the differences between biosimilar and generic medicines, the attribution of these categories to the same medicine is inconsistent. A reform of the regulatory framework in Spain is considered appropriate, as well as the introduction of a legal concept of biosimilar medicine in the European Union.