Drug shortages: the situation with generics is worsening
Published: Tuesday, Jun 25th 2024, 10:10
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The next crisis is looming on the European generics market. At the end of May, the European Commission's Committee for Medicinal Products for Human Use (CHMP) announced the temporary suspension of marketing authorizations for various generics. This is likely to exacerbate the shortage once again.
Specifically, it concerns generics that were tested by the Indian company Synapse Labs. The reliability of the test data was not sufficiently proven, as a scientific assessment by the European Medicines Agency (EMA) had previously shown.
At the end of May, the CHMP confirmed its original recommendation from December to suspend or refuse marketing authorization for several hundred of these products. "For the majority of medicines tested by Synapse Labs on behalf of EU companies, the CHMP concluded that the supporting data were insufficient or inadequate to demonstrate bioequivalence and therefore recommended the suspension of marketing authorizations for these medicines," the EMA's communiqué states. This means that data must be submitted to prove that the generics release the same amount of active substance in the body as the reference medicinal products.
The list includes well-known generics manufacturers such as Sandoz, Stada, the Israeli company Teva, the US company Mylan and the Indian companies Aurobindo Pharma and Dr. Reddy's. They are all among the Synapse customers affected by the European bans.
The EU has a strict and rigorous approval procedure for medicinal products. This is intended to ensure that medicines meet the highest standards. At the same time, the authorities are seeking to reassure the public. There are no indications of danger or lack of efficacy for any of the medicines in question, the May communication continues. "However, the marketing authorizations for the medicinal products have been suspended until supporting data from more reliable sources is available."
When asked by AWP, Swissmedic assured that it had already been informed of the results of the European investigation into Synapse in December. As the Swiss Medicines Agency had identified fewer than ten affected preparations, it did not consider it appropriate to issue a press release on the subject. However, the holders of the relevant marketing authorizations were invited to comment and submit new bioequivalence studies from other sources.
Those submitted since then have been accepted without exception, while some authorization holders have simply renounced their authorization, explained an official from the Swiss Agency for Therapeutic Products.
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