By 2020, eight countries in the European Union could save a cumulative total of between EUR 11.8 billion and 33.4 billion through the use of biosimilar medicines.
Published in the German medical industry trade magazine Monitor Versorgungsforschung, this new IGES study, called “Saving money in the European healthcare systems with biosimilars,” follows a 2008 study focused specifically on Germany.
Commissioned by Sandoz and conducted by the Berlin-based IGES institute, the new study calculated the amount of expected savings from introducing biosimilars to eight countries in the European Union: Germany, France, the UK, Italy, Spain, Sweden, Poland and Romania.
“This new IGES study highlights the value and importance of biosimilars for the future of healthcare,” says Ameet Mallik, Sandoz’s Head of Biopharmaceuticals and Oncological Injectables.
Mallik continued, “From our own experience as the pioneer and leader in biosimilars, we have witnessed how the use of biosimilars can increase patient access and reduce expenditures on biologics.”
The IGES study was limited to three classes of biologics: erythropoetin alfa (EPO) and granulocyte colony stimulating factors (G-CSF), for which biosimilars already exist, as well as monoclonal antibodies (mAbs).
EPO and G-CSF represent two of three biosimilars currently on the market and mAbs represent the fastest growing segment of the biologics market with several coming off patent in the next few years.
The study team at IGES then developed different scenarios based on possible developments of market share, pricing and the time period for market entry of biosimilars after patent expiration.
“The substantial sums spent on biologics lead to additional burdens for healthcare systems, resulting in the implementation of cost-saving measures that impact the consumers,” says Professor Bertram Haeussler, IGES Director. “Our latest study validates that biosimilars can help ease the pressure on healthcare systems.”
Biosimilars are follow-ons to biologic medicines that have lost patent protection and are approved via stringently defined regulatory pathways on the basis that they have demonstrated comparable quality, safety and efficacy to their reference product.
Biosimilars exhibit high molecular complexity compared to regular generic medicines, and therefore have higher development costs. Biosimilar development requires substantial time and investment.
A typical biosimilar takes 7-8 years to develop, at a cost of between USD 100 and 250 million, with clinical trials that may typically involve several hundred patients.
To realize the savings through biosimilars, the IGES study supports and proposes faster access to the market for biosimilars after patent expiry and encourages interchangeability between reference drugs and biosimilars - similar to original and generic drugs.