Failings at an Indian CRO have tripped up Novartis ($NVS) and Teva ($TEVA) as the European Medicines Agency (EMA) today said it would suspend both some approved generic drugs as well as some under review because of problems uncovered by the FDA at the CRO. Novartis and several other drugmakers were able to escape the holds on some products because they had additional data to support them.
The EMA today announced that because of problems uncovered by the U.S. FDA and the World Health Organization (WHO) with studies done at a Bangalore site of Semler Research Centre, it had decided to suspend sales and consideration of applications for drugs that had relied solely on bioequivalence studies from the site.
According to a list of suspended drugs and applications, Teva and Sandoz, the generic unit of Novartis, both had antimalarial drugs approved in Belgium that were affected and Sandoz had an HIV antiviral approved in that market that also will be on hold. Both drugmakers had drug applications for generic versions of Roche’s cancer med Tarceva pending in a variety of markets in Eastern Europe that also are on the list.
Sandoz, as well as Mylan and India’s Lupin, all had some drugs that the EMA has said will be unaffected because the drugmakers had established bioequivalence through other sources.
The findings from FDA and WHO inspections called into question the quality management systems at Semler, and so the reliability of data for all bioequivalence studies there, the EMA said today. The FDA in April sent a letter to Krathish Bopanna--president and CEO of Semler--that failure to adhere to statutory requirements has undermined submissions in support of Abbreviated New Drug Applications, or New Drug Applications.
The same kind of issues with CRO GVK Biosciences, another Indian CRO, last year led the EMA to suspend sales of more than 700 drugs in the EU, until companies could get alternative data submitted. While many of the products were made by Indian drugmakers, some were produced by U.S. companies like Mylan ($MYL) and Abbott ($ABT). That suspension led to heated trade negotiations between the EU and India.