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


Availability and affordability of biosimilar medicinal products, containing monoclonal antibodies in Bulgaria
Oral presentation


Stefka Stoyanova1, Emanuil Yordanov1, Еmil Hristov1, Iva Parvova2, Hristo Tzachev1, Valentina Petkova3
1Faculty of Chemistry and Pharmacy, Sofia University “Saint Kliment Ohridski”, Sofia, Bulgaria
2Clinic of Rheumatology, Department of Rheumatology, Medical University - Sofia
3Faculty of Pharmacy, Medical University - Sofia, Bulgaria


The entry into clinical practice of biological medicinal products (BMP) more than 10 years ago raised complex regulatory issues as well as significant pharmacoeconomic concerns, because the costs of these therapies are higher than conventional medicinal products. The periods of “data exclusivity” of the BMPs expired and on the pharmaceutical market are available so called biosimilar medicinal products (BSMP). The market share of BSMPs is expected to increase gradually and lead to cost reductions and increased patient access to biological treatment. Aim of study is to analyze the availability and affordability of BSMPs containing monoclonal antibodies and determine the drug utilization in Bulgaria. Materials and methods: Design - retrospective study of public available data from registers of EMA, National Council on Prices and Reimbursement of Medicinal Products and National Health Insurance Fund for the period 2015-2019. The results were processed by descriptive statistical methods. Results and discussion: On the ЕU level, BSMP with Marketing authorization are medicinal products with INN Adalimumab, Infliximab, Rituximab, Bevacizumab и Trastuzumab. In the Bulgarian Positive Drug List are included 12 BSMPs with the same INN, excluding Bevacizumab. The total cost of BMP for the period is 691 673 158 BGN - the share of BSMP in absolute value is 34 139 639 BGN, or 4,7 %. The share of biosimilar Infliximab is 31 405 331 BGN or 92 % of the total cost of BSMPs due to the lack of a reference Infliximab for the period 2015-2018. The objective conclusion is that the access of BSMPs to the Bulgarian market is still very limited.BSMPs are available and although they fall in the lower price range, the reference are the preferred treatment
Keywords: Biosimilar medicinal products, availability, affordability