EMA suspends generic drugs on data integrity concerns

Marketing approvals for dozens of generic medicines sold across Europe have been suspended by the EMA because the studies used to support approval are suspect.

The EU regulator has taken the step for a host of generics that rely on bioequivalence studies conducted at an Indian contract research organisation (CRO) - Bangalore-based Semler Research Centre Pvt Ltd - after an inspection by the US FDA found evidence that study data had been manipulated.

Meanwhile, the World Health Organization (WHO) has also raised serious concerns regarding data integrity and manipulation of study samples following its own inspections of Semler's bioanalytical and clinical sites, according to the EMA.

Bioequivalence studies generally form the basis for approval of generic medicines and show that the drug has similar characteristics to the original drug brand.

Included in the lengthy list of medicines affected by the suspension are products sold by Sandoz, Teva, Mylan, Sanofi, Biogaran Ratiopharm, Glenmark and Accord Healthcare, amongst many other firms, and most EU countries are affected by the ban.

The EMA says it has also placed a hold on approving any new product marketing applications that refer to Semler bioequivalence studies.

An FDA warning letter sent to Semler's chief executive Krathish Bopanna in April indicates that the agency has "significant concerns about the validity and reliability of bioequivalence and bioavailability data generated by your firm."

Specific issues highlighted in the letter included swapping plasma samples taken from test subjects with earlier samples that had already been tested, as well as poor record-keeping and flaws in sample storage.

Last year, the EMA also suspended marketing authorisations for scores of products relying on bioequivalence data provided by GVK Biosciences after uncovering similar issues.

"The findings from FDA and WHO inspections call into question the quality management system in place at Semler, and thus on the reliability of the data of all bioequivalence studies," said the EMA in a statement.

To guard against possible shortages of critical medicines, the agency has indicated that EU member states may be able to postpone the suspension temporarily.