Interchangeability approaches for biological and biosimilar medicinal products

Interchangeability approaches for biological and biosimilar medicinal products

Poster

Nedelko Nedelkov1, Emanuil Yordanov2, Emil Hristov2, Iva Parvova3
1National Council on Prices and Reimbursement of Medicinal Products - Sofia, Bulgaria
2Faculty of Chemistry and Pharmacy, Sofia University “Sv. Kliment Ohridski” - Sofia, Bulgaria
3Rheumatology Clinic, Department of Internal Medicine, Medical University - Sofia, Bulgaria

The aim of the study is to define definitions such as interchangeability, switching and substitution in biological treatment, incl. biosimilar products, to evaluate the applicability of the concept of equivalence/bioequivalence to these products and to review the scientific and regulatory approaches for the interchangeability of biological and biosimilar medicinal products with biological and/or biosimilar and their application in real practice. Materials and Methods: We conducted a content analysis and document analysis of published guidelines from EMA, FDA, guidelines from European and international scientific organizations and national pharmacotherapeutic guidelines. Results: At EU level, biologicals and biosimilars are authorized by EC, respectively EMA, under a centralized procedure. The 'substitution/interchangeability/switching' decisions of biological and biosimilar medicines are not part of the authorization procedures. Such decisions are responsibility of the national competent authorities and are outside of the competence of the EMA. EU Member States have access to the scientific evaluation carried out by the CHMP and all the information submitted to substantiate their decisions. Interchangeability of medicinal products is possible and acceptable - the same therapeutic indications, the same dosage form, the same amount of active substance, the same dosage regimen and the same route of administration are available. Interchangeability is acceptable, not only in terms of the quality of such biological medicinal products, but also in terms of safety and efficacy. However, decisions of this nature not always are based on scientific criteria, rather they depend on financial, economic and psycho-social factors.
Keywords: Biologicals, biosimilars, interchangeability, switching, substitution