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Biosimilars, the “generics” of biological drugs that lower prices

Biosimilar medicines are generally marketed at 20% or 30% less than original biological drugs and there are studies that estimate that in Spain the arrival of these biosimilars would have meant a saving of 5,162 million euros between 2009 and 2009. 2022. However, its use in Spanish healthcare only accounted for 3% of hospital pharmaceutical spending in 2018, according to the example offered by the Organization of Consumers and Users (OCU); that is, about 297 million out of a total of 9,914 million euros. Figures that are well below the European average. Of course, Andalusia, along with Castilla-La Mancha and Asturias, was one of the autonomous communities that used this type of drugs the most.

But what are biological medications and their “generics”?

Medicines are divided into two large groups: those of chemical synthesis and those of biological origin. While the former, those considered traditional (ibuprofen, paracetamol or aspirin), being small molecules, can be prepared relatively easily in a laboratory through chemical formulation, the latter require living cells for their production. This group includes hormonal drugs (insulin, growth, red blood cell stimulation factors), antibodies, heparins or vaccines that, for the most part, are used and dispensed in hospitals and that, as a general rule, are extremely expensive, That is the importance of biosimilars.

These are the equivalent of generic medications to traditional ones in the sense that they are drugs that compete with the original when it is no longer protected by patent law. The difference between biosimilars and generics is that, while generics are exact chemical versions of the active ingredient that they copy, biosimilars, being medications produced by living cells, it is impossible for them to replicate an exact copy of the original biological and they always present certain structural variations with respect to this.

However, this structural variability has no clinical importance, as the OCU points out, and, in fact, the European Medicines Agency (EMA), to authorize the marketing of a biosimilar, requires that the pharmaceutical company demonstrate through different studies that the new biosimilar that it intends to market is comparable to the original biological in terms of safety, efficacy and quality.

What does vary a lot is its price, 20% or 30% lower. And even more, the laboratory that markets the original medicine, in turn, lowers the price so as not to be left out of the market for drugs financed by the public health system.

In Spain there are 57 biosimilar medicines marketed corresponding to 16 active ingredients and, for example, the original biological Herceptin – whose active ingredient is trastuzumab – a monoclonal antibody that is used for the treatment of different types of cancer such as breast cancer – has a market price of 596 euros. In contrast, its biosimilar Zercepac costs 398 euros, 33% less, according to OCU data.

Also among the original biologicals authorized in Spain are the drugs Humira and Remicade, corresponding to the active ingredients adalimumab and infliximab, used in the treatment of autoimmune diseases, whose biosimilars are Amgevita and Remisima; and the drug Mabthera, whose active ingredient is rituximab, a monoclonal antibody used to combat different types of cancer and also rheumatoid arthritis, whose “generic” is Rixathon.

The OCU joins the recommendation of both the Independent Authority for Fiscal Responsibility and the National Commission of Markets and Competition regarding the promotion of biosimilars in Spain because they are “an effective and safe alternative to the original biologicals that allow the release economic resources for other health needs and help guarantee patients’ access to this type of biological medicines, which are generally extremely expensive.