Germany latest country to suspend generics following GVK Biosciences concerns

11 December 2014

The German regulator BfArM has suspended drugs including some produced by Dr Reddy’s (NSE: DRREDDY), Mylan (Nasdaq: MYL) and Stada Arzneimittel over concerns about clinical trials conducted by GVK Biosciences.

Trials carried out at the company’s site in Hyderabad, India, have triggered safety concerns in multiple products, and authorities in France, Germany, Belgium and Luxembourg have suspended approval of 25 drugs on this basis. Concerns are based on anomalies found in electrocardiograms in bioequivalence studies.

Generic versions of Bristol-Myers Squibb (NYSE: BMY) and Sanofi’s (Euronext: SAN) Plavix (clopidogrel) and AstraZeneca’s (LSE: AZN) Nexium (esomeprazole) have been affected by the suspension. Drug manufacturers, wholesale dealers, medical stores and other outlets have been ordered to suspend the drugs, though BfArM have assured that this will not lead to shortages.

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