In the next few years, the patents on about a dozen biologic drugs will expire. A decisive stage begins for a second generation of biosimilars in Spain. A stage that we cannot miss. Data from recent studies suggest that biosimilar medicines will generate savings of 1.500 million euros between now and 2020, in addition to favoring and increasing access to biological medicines and promoting pharmaceutical innovation.
Currently in Spain, the biosimilar medicines market shows a development below the average of the reference European countries: Germany and France. There are two fundamental reasons that explain this situation. On the one hand, the lack of a policy that promotes the biosimilar medicine. On the other hand, the price approval system to which the Spanish Administration submits these products, equating them to generic drugs by including them in the Reference Price System.
It is true that biosimilar medicines, like generics, offer the same guarantees of quality, safety and efficacy as the original products and are guaranteed and accredited by the European Medicines Agency (EMA) and approved by the European Comission. But there are big differences in terms of their manufacturing process and development cost; and also in how they are used by healthcare professionals.
Therefore, implementing a pricing and financing system that does not take into account the special characteristics of biosimilar medicines could have a serious impact on the sustainability of the industry, unable to face the high manufacturing costs of this type of products and the discounts conditions to which these medications are subjected. But it can also have very negative consequences for the National system of health (SNS) and for the patients themselves who, faced with a possible decision by laboratories not to invest in the production of biosimilars in Spain (given the economic situation facing them), would see their access to biological treatments limited for serious diseases.
For this reason, it is necessary to establish a proper regulatory framework for the biosimilar medicines sector. Undoubtedly, its future depends on the approval of a new law that follows the trail marked by the European Union. A law stating that only a physician can exchange a biotech drug for a biosimilar drug; and where the concepts of "interchangeability" and "substitution" are clarified.
“It is important that a correct knowledge of biosimilar medicines is implemented”
It is also very necessary to develop an information and training policy that deactivates the unfounded misgivings about biosimilar medicines that have arisen among certain market players. And it is important that it is the health administrations that take a step forward in this sense, and implement a correct knowledge of these drugs. Likewise, the Autonomous Communities, with the support of the Ministry of Health, should promote systems to encourage the prescription and use of biosimilars as an essential measure to encourage cost containment and the access of more patients to biological treatments.
Biosimilars represent a paradigm shift and the health administration must promote information policies that help doctors and patients understand the scientific support that supports and guarantees them. The foundations must be laid so that the experience of generic drugs is not repeated with biosimilars.
Angel Luis Rodriguez de la Cuerda
General Director of AESEG