Europe: Pause recommended for 100 generics
Approval for around 100 generics in Europe is to be suspended because a contract institute in India has worked poorly in the studies relevant to the approval of the drugs.
Frankfurt In Europe, around 100 copycat drugs could soon be taken off the market, at least temporarily. The Committee for Medicinal Products for Human Use at the European Medicines Agency (Ema) has recommended suspending the approval of several dozen of these so-called generics. The reason for this are irregularities in studies relevant to approval that an Indian contract institute has carried out for the drugs concerned. It is not yet foreseeable to what extent patients will now have to expect delivery bottlenecks for generic medicines.
According to Ema, a total of 49 drugs are affected in Germany. Where approval has already taken place on the basis of the data, it will be suspended. Approval procedures based on the Institute’s study data will be stopped for the time being. The list ranges from widely used cholesterol-lowering drugs such as atorvastatin to painkillers such as ibuprofen and the migraine drug zolmitripan.
Manufacturers of the affected drugs include well-known generic companies such as Hexal/Sandoz, Ratiopharm/Teva and Stada. Copycat drugs can be brought onto the market after patent protection has expired and significantly reduce consumer prices for the active ingredients in question.
The responsible Federal Institute for Drugs and Medical Devices (Bfarm) is currently examining the situation in Germany, as the authority informed the Handelsblatt on request. Final statements could not be made yet. “The goal is to avoid supply bottlenecks,” says the Bfarm. For individual medicines that are of critical importance in their countries, national authorities in the European Union (EU) can also decide that they remain available until new data become available, according to Ema’s announcement.
Patients taking the affected medicines are advised to contact their doctor or pharmacist for alternative medicines. According to Ema, there is no evidence of damage or lack of effectiveness in any of the drugs concerned. The suspension of the approvals for these medicines will be ordered pending supporting data from more reliable sources.
The contract institute where the irregularities in the conduct of studies were found is called Synchron Research Services and is based in Ahmedabad, India. Specifically, it is about deficiencies in so-called bioequivalence studies. These are carried out to prove that a generic medicine makes the same amount of active substance available in the body as the reference medicine. According to Ema, “serious concerns have arisen about the quality management system” of the institute and “the reliability of the data collected at this site”.
In an initial statement, the Pro Generika industry association referred to the authority’s statement that there were no indications of damage or lack of effectiveness for any of the drugs concerned and that alternative drugs were available. “The companies concerned will now have to decide whether to commission additional studies and leave their preparations on the market in consultation with the authorities. However, we do not yet have a complete overview of this,” said the association at the request of the Handelsblatt.
The FDA already inspected the institute last year
An inspection of the institute initiated by the US Food and Drug Administration (FDA) last year got the ball rolling. As a result, the European authority also checked the study data for preparations approved in Europe.
The European Commission still has to make a legally binding decision on the committee’s recommendation to suspend approvals for generics. As a rule, however, the Commission follows these recommendations. Affected manufacturers who want to lift the suspension of the approval must then submit alternative data to prove bioequivalence.
Delivery bottlenecks for medicines always make headlines. Among other things, they benefit from market structures that have developed over many years. Consolidation and cost pressure in the past two decades, especially among suppliers of inexpensive imitation products, have led to the production of active ingredients being increasingly concentrated, relocated to low-wage countries or completely outsourced to low-cost suppliers. The shift often takes place in Asia. Although various manufacturers still press their own tablets, the active ingredient often comes from one and the same supplier.
At the beginning of this year, there were bottlenecks in Germany for the breast cancer drug tamoxifen because suppliers had withdrawn from production. Impurities in the active ingredient imported from China caused a shortage of the antihypertensive drug valsartan in 2018/19. There have also been problems with a contract research institute: In 2014, Bfarm suspended the approval for around 80 generic drugs after irregularities were discovered in the studies by the Indian contract institute GVK Bioscience relevant to approval.
May 25, 20220
