EMA Suspends 136 Drugs Due to Flawed Bioequivalence Studies

The European Medicines Agency is recommending halting sales of 136 drugs whose approval came from flawed bioequivalence studies performed at the Semler Research Centre in India.

Medicines for which bioequivalence studies were conducted at Semler are under scrutiny after an inspection of the research site found “substitution and manipulation” of study samples, EMA stated in a report published July 22. The World Health Organization found data integrity issues and manipulation of study samples during its inspection Semler’s bioanalytical and clinical sites.

The potentially suspended generic medicines affect manufacturers ranging from Sandoz and Teva to Mylan and Lupin.

Drugs under evaluation based on studies from the site shouldn’t be authorized until alternate data is provided, even though there is no current evidence demonstrating lack of effectiveness or harm, the agency recommended.

EMA noted that EU member-states could temporarily postpone the suspension if the affected medicines are of critical importance.

A list of EMA’s suspended drugs can be found here: www.fdanews.com/07-22-16-EMARecommendedSuspension.pdf. — Joya Patel

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