Abstract
Background:Monoclonal antibodies (mAbs) represent the most numerous and significant group of biotherapeutics. While mAbs have undoubtedly improved treatment for many chronic diseases, including inflammatory diseases, they are typically expensive for health care systems and patients. Consequently, access to mAbs has been a problem for many patients especially among Central and Eastern European (CEE) countries. However, biosimilars can potentially help with costs, although there are concerns with their effectiveness and safety. This includes biosimilars for long-acting insulin analogues.Aim:Assess the availability and use of biological medicines, including biosimilars within Bosnia and Herzegovina (B&H).Methods:Assess the availability of mAbs via the current lists of approved and accessed mAbs versus those licenced in Europe and the United States and their utilisation, as well as specifically insulin glargine and its biosimilars, within B&H.Results:The availability of the mAbs in B&H appears satisfactory, which is encouraging. However, current usage is limited to a few mAbs which is a concern for subsequent patient care especially with limited use of biosimilars to address issues of affordability. We also see limited use of biosimilar insulin glargine.ConclusionThe limited use of mAbs including biosimilars needs to be addressed in B&H to improve the future care of patients within finite resources. We will monitor these developments.
Highlights
IntroductionMonoclonal antibodies (mAbs) represent the most numerous and most significant group of biotherapeutics, with biological medicines for disease areas, such as cancer and inflammatory diseases dominating medicines expenditure.[1] The importance of mAbs has grown in recent years as they offer treatment options for patients with chronic and often disabling conditions, including autoimmune diseases.[2,3,4] mAbs are expensive limiting their prescribing among Central and Eastern European (CEE) countries, including patients with rheumatoid arthritis and inflammatory bowel disease, which needs addressing under solidarity principles.[5,6,7] There are considerable differences in the availability and use of new oncology medicines across Europe, enhanced by cost issues.[8,9] A reduction in the prices of mAbs through biosimilars can result in appreciable savings as well as increasing the number of patients accessing these medicines especially where there are high co-payments, alternatively budget concerns.[5,10,11] While price reductions for biosimilars versus pre-patent originator prices have often been limited, this is changing as seen for Humira® (89% price reduction) in the Netherlands and its biosimilar in Denmark (83% price reduction) and the United Kingdom (75% price reduction).[10,12,13] This provides hope for the future
Monoclonal antibodies represent the most numerous and most significant group of biotherapeutics, with biological medicines for disease areas, such as cancer and inflammatory diseases dominating medicines expenditure.[1]
MAbs are expensive limiting their prescribing among Central and Eastern European (CEE) countries, including patients with rheumatoid arthritis and inflammatory bowel disease, which needs addressing under solidarity principles.[5,6,7]
Summary
Monoclonal antibodies (mAbs) represent the most numerous and most significant group of biotherapeutics, with biological medicines for disease areas, such as cancer and inflammatory diseases dominating medicines expenditure.[1] The importance of mAbs has grown in recent years as they offer treatment options for patients with chronic and often disabling conditions, including autoimmune diseases.[2,3,4] mAbs are expensive limiting their prescribing among Central and Eastern European (CEE) countries, including patients with rheumatoid arthritis and inflammatory bowel disease, which needs addressing under solidarity principles.[5,6,7] There are considerable differences in the availability and use of new oncology medicines across Europe, enhanced by cost issues.[8,9] A reduction in the prices of mAbs through biosimilars can result in appreciable savings as well as increasing the number of patients accessing these medicines especially where there are high co-payments, alternatively budget concerns.[5,10,11] While price reductions for biosimilars versus pre-patent originator prices have often been limited, this is changing as seen for Humira® (89% price reduction) in the Netherlands and its biosimilar in Denmark (83% price reduction) and the United Kingdom (75% price reduction).[10,12,13] This provides hope for the future.
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