There are many expectations aroused by the incorporation of the new generation of biosimilars to the market. As administrators, we are drivers of your access more than other stakeholders who may have a less defined position or even be a barrier.
The sustainability of National system of health (SNS) is a crucial aspect if we want to maintain a wide coverage; and the incorporation of biosimilars for prevalent or high-impact pathologies constitutes an expectation of savings by giving entry to the competition of drugs with very significant costs. However, it is probable that this foreseeable decrease in spending will be less than expected since it will be possible to facilitate access to a greater number of patients.
Intense activity around new biosimilars can be detected.
Some have already achieved approval such as the infliximab, and the procedure for fixing the price and financing conditions will begin. Others are in the clinical investigation phase or in the preclinical phase, they are antineoplastic biologics, colony-stimulating factors and anti-TNF (tumor necrosis factor) with great potential for the treatment of many patients.
"There are many expectations aroused by the incorporation of the new generation of biosimilars to the market"
On the horizon are also new biologics (biobetters) that, claiming improvements, may influence the entry of biosimilars. It will be necessary to consider all these aspects to assess the incorporation into the market of biological products.
From the SNS are being carried out several actions to create a favorable environment for the incorporation of biosimilar medicines:
- Price drop in relation to the reference product, negotiable depending on different parameters and on a case-by-case basis. This has been done with currently available biosimilars, with which an average reduction of 30% is achieved, higher for filgrastimFollowed by epoetin, and a smaller decrease for somatropin with respect to the reference product.
- Although the Law considers biological products to be non-substitutable, the generalized prescription by active principle gives priority to the biosimilar, which constitutes a support tool for the initiation of treatments with biosimilar drugs.
- At the state level, information and knowledge exchange days have been organized between interested parties to promote a common understanding based on evidence.
- At the industrial level, the industries of biological products are encouraged.
On the European scene, according to data from IMS Health, Spain shows, for biosimilars currently available, high market share figures, only surpassed by Italy and France in share by volume; and also by Germany in quota by value. In this European context, Spain has participated in the drug access group of the General Directorate of Enterprise of the European Union, which addressed the issue of biosimilars and prepared an informative consensus document in relation to these products.
Time will gradually place biosimilars in their proper place. However, at this time, there are many uncertainties and positions, sometimes contradictory, on various aspects that may more or less favor their incorporation: Can the indications be extrapolated? Can they be interchangeable from a medical point of view? And what about patients who have already started treatment? Can they be substitutable at the dispensation level? By concept, should they be part of reference groups? Why a different international nonproprietary name?
Only evidence and clinical practice will be able to elucidate all these issues. Meanwhile, a favorable environment and adequate monitoring must be tools that allow the development of this market.
Piedad Ferre
DG Basic Portfolio of SNS Services and Pharmacy
Ministry of Health, Social Services and Equality
