or a new biosimilar for an existing product , with no change indication ). 5
Estimates of savings resulting from the introduction of biosimilars in the US market over a ten-year period range from 25 to 100 billion dollars , but these estimates can vary greatly depending on the assumptions made regarding uptake , implementation policies , and price discounts . 3 The cumulative potential savings to health care systems in the EU and US may be more than 50 billion Euros . However , in many cases , the savings are calculated merely taking into consideration direct competition for the reference product , while excluding indirect competition for other in-class products . 1 In order to maximise price competition , the regulatory agencies and reimbursement and procurement entities should consider both the clinical and economic value of a biosimilar , not only through direct comparison with the reference product , but also against the other medicines in the same class or used for the same indication . 5
The generation of high-quality and comprehensive outcomes data sets on the effectiveness and safety , as well as impacts on budgets and cost savings , should be encouraged
The sustainability of the market is certainly important , and focusing on price only poses constraints to the long-term savings that can be obtained with biosimilars , thus creating less attractive conditions for manufacturers to invest in the development of new products . An expanded availability and diversity of biosimilars brings benefits to patients and physicians , who have more options to customise treatment plans along the course of the disease , ultimately improving outcomes for patients . 1 In the EU , the use of biosimilars has resulted in reduced average list prices for the originators as well as for the entire therapeutic class , 6 but the extent by which the competition affects pricing is highly variable between molecules , therapeutic areas , and regions . Moreover , the evaluation of the impact of a competitive biosimilar market is restricted by the unavailability of data on discounts and rebates offered to the different countries and institutions , which are often kept confidential . 3
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