Unlike in the US, biosimilar versions of biopharmaceutical drugs have been available in Europe since the EMA approved a version of Pfizer’s growth hormone Genotropin (somatropin) in 2006.
Last year the agency approved the first monoclonal antibody biosimilars – versions of Janssen’s Remicade – but a number of biologics coming off patent in the next six years could cut European healthcare spending by a quarter, according to a study on behalf of the European Biosimilars Group (EBG), a sector of the European Generic medicines Association European (EGA).
The study focused on three topselling mAbs with an early, mid-term and late-entry into the market. A Herceptin (trastuzumab) biosimilar is expected to be launched in 201-16, Humira (bevacizumab) in 2018-20, and Avastin (adalimumab) 2020-22, but for all three the cumulative cost savings over the 10 year period from the entry of its first biosimilar will be 26%, 24% and 25% respectively.
These figures are based on the optimal policy combination identified by GfK Market Access which carried out the study calculated by considering the cumulative budget impact of the originator if biosimilars did not enter the market minus the cumulative budget impact of the originator plus biosimilars, and specifically for healthcare providers in France, Germany, Italy, Spain, and the UK.
According to EGA director general Adrian van den Hoven, the market is currently entering a second phase of biosimilars with mAbs leading the way.
“The introduction of mAbs is an exciting new development for healthcare in Europe,” he told Biopharma-Reporter.com. “It shows once again that Europe remains the leading market for biosimilar medicines from both the progress in regulatory science and the uptake.”
However, the study warned these conditions relied on awareness and understanding of accurate unbiased information which “needs to be improved, as does awareness and understanding of the requirements for a sustainable biosimilar medicines market.
“Unless addressed this will be a barrier to uptake and the delivery of continuing benefits to all stakeholders in both the short and long term.”
We asked Van den Hoven what problems still exist in Europe regarding biosimilar uptake. “Some countries have very little uptake of biosimilar medicines currently on the market because their pricing and reimbursement or hospital purchasing rules make it very difficult to bring competition to the biopharmaceuticals market.
“[The EGA] want to engage in a dialogue with the authorities to change this. We also see the need to improve the flow of unbiased information from the authorities toward hcps and patients. Many countries in europe are facing severe financial constraints in their pharmaceutical budgets and are consequently taking measures to support biosimilar medicines competition in the biopharmaceuticals market.”