A headache ahead for the member states of the European Union (EU). The European Commission has notified the Twenty-Seven of the suspension of marketing authorizations for several hundred generic medicines marketed on the continent. Brussels, which is based on an opinion issued by the European Medicines Agency (EMA), invokes “insufficient evidence regarding the reliability of test data”in particular bioequivalence studies, which aim to demonstrate that a generic medicine releases the same quantity of active substance in the body as the reference medicine it copies.
Pharmaceutical laboratories are called upon to put things in order as quickly as possible by providing new scientific data that complies with European quality requirements. Problem: the list of notified medicines, from which no Member State escapes, is long. The EMA has nearly 2,250 references affected, with Germany leading with 208 references, ahead of the Netherlands (188), Portugal (112) and France (98).
In practice, the figure is smaller, many of them concerning the same medicine sold in presentations (capsules, tablets, injections, powder to dilute, etc.), dosages and in different countries. Thus, for France, the National Agency for the Safety of Medicines and Health Products (ANSM) lists altogether 72 affected generics.
Put in danger
Despite everything, redoing bioequivalence studies requires time, and the Commission’s injunction could jeopardize the already precarious balance of the supply of health products on the continent. Should listed generics be withdrawn from sale, at the risk of creating shortages of drugs that are harmful to patients, or should these products with non-compliant regulatory files be kept on the market while awaiting their regularization? Brussels leaves the choice to each Member State to decide, product by product, on the course of action to follow, by giving the possibility of postponing the suspension for two years for generics deemed “ of crucial importance at national level ”, and whose existing alternatives may not be available in sufficient quantities.
France has not yet decided. The ANSM must decide on the 72 generics identified in France before June 24. Among the treatments in the hot seat are several antiretrovirals, used in the treatment of HIV infection (AIDS), antidiabetics (metformin, sitagliptin, vildagliptin), anticancer drugs targeting breast, pancreatic or blood cancers, antiepileptics (topiramate, lacosamide), but also generics of olanzapine, indicated in bipolar disorders and schizophrenia, betahistine (against dizziness) or even propofol, an anesthetic common in hospitals, and tadalafil, copy of the reference drug Cialis, known for its effects similar to the very popular Viagra.
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