Saving money in the European healthcare systems with biosimilars
Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 3
Abstract
Introduction: The use of biotechnological manufactured drugs, or biologicals, has increased massively over the past few years. Used especially in the treatment of cancer and other severe diseases, biologicals incur high annual therapy costs and represent an additional burden for healthcare systems. Expenditure can be decreased by using cheaper biosimilars, produced following the patent expiration of the reference product. Here we present a model calculation that demonstrates the potential savings from using biosimilars for erythropoietins, granulocyte colony-stimulating factors, and monoclonal antibodies in EU national markets between 2007 and 2020. Methods: Using a sequential approach, we calculated the savings through the use of biosimilars for France, Germany, Italy, Poland, Romania, Spain, Sweden and UK. First, either a ‘top-down’ or a ‘bottom-up’ approach was chosen to forecast the expected quantity of consumed drugs. We then calculated average reimbursement prices using additional information about the healthcare systems in each country. Finally, we estimated the potential savings for the above molecule groups using developed country specific scenarios. Results: The use of biosimilars is expected to result in overall savings between Euros 11.8 billion and Euros 33.4 billion between 2007 and 2020, with largest savings expected for France, Germany and UK. Biosimilar monoclonal antibodies are expected to produce the greatest savings ranging from Euros 1.8 billion to Euros 20.4 billion. Biosimilar erythropoietins are expected to provide savings of between Euros 9.4 billion and Euros 11.2 billion, while granulocyte colony-stimulating factors could produce savings of between Euros 0.7 billion to Euros 1.8 billion. Conclusion: The increasing use of biosimilars is a valid option for decreasing healthcare expenditure on biological drugs.
Authors and Affiliations
Robert Haustein, Christoph de Millas, Ariane Höer, Bertram Häussler
The generic pharmaceutical industry: moving beyond incremental innovation towards re-innovation
Background: Due to the declining innovativeness of the classic R & D model in the original pharmaceutical industry, the generic pharmaceutical industry is aiming to become an innovation generator itself. Objective: The o...
Equal protection under the law: Children and the Best Pharmaceuticals for Children Act
Four changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act will markedly improve these programmes: expanded attention paid to neonatal studies, support for the off -patent programme,...
Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of ciclosporin, tacrolimus and mycophenolate mofetil
This position paper deals with our regulatory opinion on registered generic immunosuppressants such as ciclosporin, tacrolimus and mycophenolate mofetil, and provides arguments why these medicines are considered equally...
The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead?
Introduction: Besides biologicals, a new class of complex drugs – non-biological complex drugs (NBCDs), e.g. liposomes, iron carbohydrate products and glatiramoids – has emerged. Originator NBCD products have been approv...
Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act
Biological (large molecule) drug products are made via living systems and are complex and variable in nature. As a result, generic forms of biological products, also termed biosimilars in the EU or follow-on biologics by...