The European Union has taken the radical decision to suspend the sale of 35 generic medicines in Spain due to their reduced effectiveness. The move is part of a wider suspension affecting more than 400 generic medicines across Europe. The European Medicines Agency (EMA) determined that the bioequivalence testing of these medicines was inadequate, leading to the decision.
Among the affected drugs are critical categories such as diabetes medications, painkillers and cancer treatments. Specific drug categories include antidiabetics such as vildagliptin, cancer treatments such as anastrozole and erlotinib, painkillers and narcotics, antiretrovirals, antiepileptics such as topiramate and lacosamide, and generic olanzapine and dysfunction medications.
The suspension is due to irregularities in bioequivalence studies conducted by Synapse Labs, an entity based in India. The European Medicines Agency found that the data provided by this company were insufficient to ensure the efficacy and safety of the medicines, leading to the decision to stop marketing them.
In Spain, the suspension affects 35 generic medicines. The Spanish Agency for Medicines and Health Products (AEMPS) confirmed that this measure will not affect patients, and that there will be no problems in the supply of medicines. Marketing of generic medicines under central license was suspended with immediate effect, while medicines given national authorization by AEMPS were withdrawn.
At European level, more than 400 medicines have been suspended. Countries such as France, Germany and the United Kingdom have also been affected, with similar numbers of medicines suspended. The immediate suspension mainly affects centrally licensed medicines, while national agencies manage the withdrawal of locally authorised medicines.
AEMPS has confirmed its commitment to patient safety and indicated that medicines can be remarketed if valid alternative studies are presented demonstrating their bioequivalence. National authorities have the possibility to delay the suspension for up to two years if the medicine is critical to the health system.
The generic medicine market represents a significant portion of the total medicines sold in Spain and Europe. In Spain, generics represent about 40% of the pharmaceutical market by volume according to data from the Spanish Association of Generic Medicines (AESEG). In other European countries, this percentage varies, but remains within a similar range. In Germany, for example, generics represent about 75% of the market by volume, while in the United Kingdom this figure is closer to 70%.
The suspension of these generic medicines highlights the importance of strict controls on the production and marketing of medicines. The EMA’s decision, supported by national authorities such as AEMPS, reaffirms the commitment to the safety and efficacy of medicines available to patients. As new studies are developed and sufficient evidence of bioequivalence is provided, some of these medicines could return to the market, ensuring continued treatment for thousands of patients across Europe.
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