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 announced on Friday 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 generics 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.
In an email, a Teva spokesperson said Monday that the one product that the company was pulling from the markets in Belgium, Denmark, Finland, France and the Netherlands was the one product affected by the EMA decision, the antimalarial atovaquone-proguanil.
A spokesperson for Sandoz responded in an email, "We are working closely with our licensing partners to repeat the bioequivalence/bioavailability studies at an acceptable alternate study site."
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 Friday. 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.