Germany Suspends 80 Generics Over Poor Bioequivalence Trials

German regulators have published a list of 80 generic medicines whose approvals were yanked after EU authorities expressed concerns with contract research organization GVK Biosciences.

On Germany’s list are generic versions of Forest Laboratories’ Lexapro (escitalopram), AstraZeneca’s Nexium (esomeprazole), Novartis’ Diovan (valsartan) and Pfizer’s Effexor (venlafaxine), from generics giants such as Mylan and Dr. Reddy’s Laboratories. All of the products had been approved based on bioequivalence studies performed by GVK Biosciences.

The decision to suspend the drugs followed a French agency’s inspection of GVK’s Hyderabad, India, facility that turned up significant deficiencies in study conduct and data validity, said Germany’s Federal Institute for Drugs and Medical Devices (BfArM). Other EU regulators also have suspended drugs vetted by GVK pending the outcome of a European Medicines Agency review.

The 80 affected drugs may not be sold in Germany until the companies submit new bioequivalence studies, BfArM says. It doesn’t expect any shortages, however, as other versions of these drugs are still available.

GVK did not return DID’s requests for comment by press time.

View the list of companies and products at www.fdanews.com//12-10-14-Germanlist.pdf. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.