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EMA halts sales of unreliable generics Posted 19/08/2016

The European Medicines Agency (EMA) has recommended that the sales of several generics, including those produced by Teva and Novartis, be suspended after data on their approval was found to be unreliable.

The EMA recommendation relates to data produced by Semler Research Center, a contract research company based in Bangalore, India. The statement comes just months after the US Food and Drug Administration (FDA) raised concerns about the quality of data generated by bioequivalence studies at Semler, stating that both clinical and bioanalytical studies conducted by the agency were ‘not acceptable’. Their inspections in late 2015 revealed widespread misconduct and violations of federal regulations causing them to issue a letter of warning to the company.

The World Health Organization (WHO) also issued a notice to Semler after finding instructions for manipulating drug samples during investigations of their computer servers.

Together, the findings cast doubt on the quality of Semler’s data, which had been used to grant approval for several medicines in the European Union. As a result, the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that any studies conducted at Semler Research Center should not be accepted for authorization.

The list of medicines recommended for suspension includes erlotinib, used to treat several forms of cancer (marketed by Roche as Tarceva) and the anti-malarial drug atovaquone/proguanil. Teva was forced to pull the anti-malarial from sale in Belgium, Denmark, Finland, France and The Netherlands, while Teva and Novartis’ generics unit Sandoz both had generic versions of Tarceva pending in several European markets.

EMA does however recognize that several of the medicines on the list are critical, and so, where there is a lack of alternatives, national authorities can choose to temporarily delay suspension for patient benefit. And, although no medicines can be approved based on Semler’s studies, the agency will allow sales of the drugs where the manufacturing company can provide bioequivalence data from other sources. The European Commission is yet to form a legally binding decision on the CHMP’s recommendations.

This decision comes as yet another blow to Indian pharma. In 2015, the EU suspended hundreds of drugs authorized by GVK Biosciences, another Indian contract research organization, due to flawed data [1]. The country’s pharmaceutical industry has faced numerous quality control concerns and received warnings and even had shipments banned by FDA. This latest news will only serve to increase scrutiny of the industry.

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1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends suspending generics from GVK Bio [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 19]. Available from: www.gabionline.net/Policies-Legislation/EMA-recommends-suspending-generics-from-GVK-Bio

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Source: Source: EMA, US FDA, WHO

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