European Union drug regulator European Medicines Agency (EMA) will suspend the marketing approval given to around 100 generic medicines due to irregularities in the bioequivalence studies carried out by Ahmedabad-based contract research organisation (CRO) Synchron Research Services.
Bioequivalence studies are conducted to show that a generic medicine releases the same amount of active substance in the body as the reference medicine.
EMA’s human medicines committee (CHMP) recommended the suspension of marketing authorisation after looking at all medicines tested by Synchron Research Services on behalf of EU companies and found that for the majority (around 100 medicines) no adequate bioequivalence data were available from other sources.
The companies whose products will see suspension of marketing authorisation include Teva, Mylan, Sandoz, Wockhardt, Aristo Pharma, Lupin, Micro Labs, Johnson & Johnson and dozens of others that sell the products across the EU member countries.
The medicines covered include amlodipine, paracetamol, dorzolamide, tianeptine, azithromycin, almiden, rosuvastatin, ibuprofen, atorvastatin, rosuvastatin, progesterone, etc. The countries whose national regulators will act upon the EMA’s recommendation include Germany, Greece, France, Denmark, Finland, Estonia, Netherlands, Ireland, Sweden, Spain, Slovenia, Slovakia, Romania, Portugal, Poland, Norway, Malta, Luxembourg, Lithuania, Latvia, Italy, Hungary, Czech Republic, Croatia, Cyprus, Belgium, Bulgaria and Austria.
To lift the suspension, companies relying on data from Synchron Research Services must provide alternative data demonstrating bioequivalence. For a small number of authorised generic medicines (around 20), adequate bioequivalence data were available from other sources, and these medicines are allowed to remain on the EU market, EMA said in a statement issued on May 20.
The agency also said that since some of the medicines that have been recommended for suspension may be of critical importance due to lack of available alternatives or other reasons, national regulators of respective EU member states can temporarily postpone the suspension in the interest of patients. The agency also said that member states will decide whether recalls of the affected medicines are needed in their territories.
Based on the CHMP's recommendation, the European Commission will issue a legally binding decision soon.