A study of five European Union (EU) countries has revealed that Germany provides the most favourable environment for uptake of biosimilars.
The study, which was led by Professor Henry Grabowski, Director of Programme in Pharmaceutical Health Economics at Duke University, Durham, USA, assessed the market experiences of biosimilars in France, Germany, Italy, Sweden and UK. Although the EU has a common regulatory system for approving biosimilars, via EMA, there were differences in reimbursement practices, incentives and medical and clinical practices across each of the Member States.
Unlike in the US, EMA has no authority to designate a biosimilar as substitutable at the pharmacy level. This decision is left to each individual Member State. To date no EU country allows the substitution of biosimilars, and in fact some countries, such as France, even specifically prohibit it.
Germany was found to be the most favourable for biosimilars due to its reimbursement policies. The country has a biosimilar reference pricing policy, plus targets or quotas for biosimilars use for physicians and sickness funds.
The UK was also found to be favourable, with its buoyant generics market and cost-effectiveness analyses of biosimilars by the UK’s National Institute for Health and Care Excellence (NICE).
Italy was found to be the least favourable country for biosimilars due to its strict price regulation system which requires a mandatory discount of 15–22% for biosimilars relative to that of the brand-name reference product.
France was also found to be a potentially favourable market for biosimilars. Although the country also has a strict price regulation system and compulsory discounts for biosimilars, high volume sales of biologicals compared to other EU countries add to the attractiveness of the market for biosimilars.
Finally, Sweden was also seen as a potentially attractive market for biosimilars. The country has some of the highest manufacturer-level prices in Europe, including for biologicals, and a decentralized system of financing by county councils.
Professor Grabowski concluded that, for the foreseeable future, biosimilar competition is likely to have fewer entrants than generics competition, given the higher cost of entry and that, consequently, the rate of biosimilar penetration will depend not only on price competition, but also on the ability of manufacturers to convince physicians and providers that quality standards are high.
The study findings are in line with those of another study into the financial benefit of switiching to biosimilars in eight EU countries – France, Germany, Italy, Poland, Romania, Spain, Sweden and UK. This study found that by 2020, the expected savings for biosimilars would range from Euros 11.8 billion to Euros 33.4 billion, which equals savings of 5.2% to 14.6% of the estimated expenditures in the selected countries. The bulk of the savings were expected to occur in France, Germany and UK, while the lowest savings were anticipated for Sweden.