Availability, affordability and drug utilization of biosimilar medicinal products, containing monoclonal antibodies in Bulgaria

Abstract

The entry of the biological medicinal products (BMPs) in the clinical practice more than 10 years ago raised complex regulatory issues as well as significant pharmacoeconomic concerns, because the costs of treatment is higher than the costs of the conventional products. The “data exclusivity” of BMPs expired and biosimilar medicinal products (BSMPs) are available on the market. The market share of BSMPs is expected to increase gradually and lead to cost reductions of biological treatment. Aim: To analyze the availability, affordability and drug utilization of BSMPs containing monoclonal antibodies in Bulgaria. Materials and methods: Retrospective study of the public data from EMA, National Council on Prices and Reimbursement and National Health Insurance Fund for 2015–2019. Descriptive statistical analysis was performed. Results and Discussion: On the ЕU level, BSMPs with Marketing Authorization are Adalimumab, Infliximab, Rituximab, Bevacizumab and Trastuzumab. In the Bulgarian Positive Drug List, there are 12 BSMPs with the same INN, excluding Bevacizumab. The total cost of BMPs is 691 673 158 BGN – the share of BSMPs is 34 139 639 BGN (4.7%). The access of BSMPs in Bulgaria is still very limited. BSMPs are available with the lower price, but the reference products are the preferred treatment. The reason for this could be the lack of national standards for the switching/interchangeability of BMPs with BSMPs, and the prescribers distrust of the so-called replacement therapies and aggressive drug promotion to the healthcare professionals are also of great importance.

Retrospective analysis of drug utilization and rational drug use in treatment of essential arterial hypertension in Bulgaria: Generic perception

“…The same medicinal product is defined as available if it is placed on the market and included in the public fund reimbursement system. 15 The updated version of the ATC/DDD Index 2020 contains 121 codes at level IV and 609 INN at level V. 10 Of these, 41 codes at IV level and 102 INN at V level can be considered available in Bulgaria as described in the medicinal products included in the PDL. At IV level by ATC, the products in Bulgaria are 3 times less than all ATC by WHO or 33.88% and as products at V level 6 times less or 16.74% (Table 1).…”

“…The same medicinal product is defined as available if it is placed on the market and included in the public fund reimbursement system. 15…”

Evaluation of the drug utilization of biosimilar medicinal products containing monoclonal antibodies: A systematic review

“…The same medicinal product is defined as accessible if it is available and included in a reimbursement system from a public, private, and/or government fund. 3,4 Biosimilar medicinal products (BSMPs) by their nature are biological medicines that are very similar to other biological medicinal products, which have already been approved in the EU-the so-called "reference biological medicinal products." The "similar biological" medicinal product and the "reference" medicinal product are expected to have the same safety and efficacy profile and are used for treatment in the same 1 Laboratory of Social Pharmacy, Faculty of Chemistry and Pharmacy, Sofia University "Saint Kliment Ohridski, Bulgaria 2 Clinic of Rheumatology, Department of Internal Medicine, Medical University of Sofia, Bulgaria 3 Faculty of Pharmacy, Medical University of Sofia, Bulgaria settings.…”

“…The same medicinal product is defined as accessible if it is available and included in a reimbursement system from a public, private, and/or government fund. 3,4…”