The biosimilar portfolio will continue to grow in 2025 and At least four generic biologics will enter the market. These already have the green light from the Ministry of Health, but they will not begin to be sold and, therefore, administered due to “patent issues”, as explained by the Spanish Association of Biosimilars (BioSim) to elEconomista.es.
It will be marketed the first biosimilar of the active ingredient omalizumab (the original is Xolair from Novartis), which is Omlyco from Celltrion. It is indicated for chronic spontaneous urticaria.
Besides, entern to compete in the Spanish market two generic denosumab biologics from Sandozspecifically Jubbonti and Wyost. Both were authorized by the Interministerial Commission for Prices and Health Products (Cipm) in its last meeting, but they will not be sold until 2025 for the reasons mentioned. It should be said that the original treatment is Amgen’s Prolia.
In parallel, the first biosimilar ‘version’ of aflibercept (the patent was from Bayer with Eylea). This is Yesafili, which is part of the Biocon Biologics portfolio and is aimed at age-related macular degeneration.
On the other hand, in 2025 the European Commission authorzará the first pertuzumab biosimilars (the original medicine is Perjeta from Roche) and golimumab (the patent is from Janssen), according to BioSim. What’s more, the latter is already being evaluated by the Committee for Medicinal Products for Human Use of the European Medicines Agency. However, the association points out that They will not land in Spain until 2026.
In 2024 Mónica García’s apartment opened the door to almost three times as many biosimilars – in terms of volume – compared to the previous year. In addition, of those mentioned above, the green light was given to the first five generic ustekinumab biologics (the original is Janssen’s Stelara), aimed at Crohn’s disease and psoriasis, according to the BioSim registry. To date, this is the molecule that generates the greatest expenditure for the National Health System along with adalimumab. In fact, in 2022 it caused a disbursement of 275,491 euros, according to data from the Ministry of Health. Biosimilars of tocilizumab, ranibizumab, bevacizumab, rituximab and etanercept, among others, also became part of the public provision portfolio.
Likewise, a study by the Spanish Association of Biosimilars and the Complutense University of Madrid estimates that the country’s portfolio of biological generics will provide savings of 2,068 million in 2024.
If you look a little further back, specifically to 2023, During that year, they were authorized five generic biological. The Ministry of Health opened the doors to Sandoz’s Tyruko, indicated for multiple sclerosis. This is the first biosimilar of natalizumab.
Besides, approved the financing of ranibizumab generic biologic (the original is Lucentis from Novartis), and the first two of eculizumab (the patent was from Alexion, with Soliris), indicated for a rare disease. It also entered the Spanish health portfolio the ‘biosimilar’ version of tocilizumab (the brand name is Roactembra from Roche) for Covid 19 and rheumatology.
In 2023, biosimilars saved 1.8 billion euros, 80% more than in 2022. It is worth mentioning that in that year, 78% of the treatments consumed in hospitals were biosimilars while in local pharmacies they represented 33%. of the medications dispensed.
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