EMA recommends suspension of medicines over flawed studies at India’s Semler

The European Medicines Agency has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, a contract research organization (CRO) with an analytical and a clinical site located in Bangalore, India.

The Agency has also recommended that generic medicines currently being evaluated for authorization and which rely only on bioequivalence studies from this site should not be authorized until bioequivalence is demonstrated using alternative data. Bioequivalence studies usually form the basis for approval of generic medicines.

The EMA's list included drugs made by some of the top generic drugmakers, including Teva Pharmaceutical Industries (NYSE: TEVA), Mylan (Nasdaq: MYL) and Novartis’ (NIVN: VX) Sandoz unit. The EMA review expressed concerns about the bioequivalence of the suspended generics of cancer drug Tarceva (erlotinib), migraine treatment eletripan and anti-malarial drug atovaquone (trade name Proguanil).