Sandoz, Teva and Mylan generics to be suspended in EU
Europe’s regulator has called for generic medicines from manufacturers including Novartis’ Sandoz unit, Teva and Mylan to be pulled from the market, after US inspectors found evidence that test data was unreliable.
At the heart of the matter is India’s Semler Research Centre, which gathered the bioequivalence data on behalf of a number of generic pharma firms.
The European Medicines Agency has published a list of those medicines that are suspended, including copies of the cancer drug, erlotinib.
Medicines under evaluation that rely on Semler bioequivalence studies should not be authorised until alternative supporting data is found, said the EMA.
The EMA review followed an inspection by the US Food and Drug Administration that identified issues at the site, including substitution and manipulation of subjects’ clinical samples.
The World Health Organization has also raised concerns about data integrity and manipulation of study samples following its own inspections.
Although the EMA’s Committee for Medicinal Products for Human Use (CHMP) top scientific committee said no medicines can be authorised or marketed on the basis of Semler data, they can be approved if there are alternative bioequivalence studies.
The EMA also published a list of medicines that are approved on the basis of alternative bioequivalence studies.
Where there are no equivalent drugs national regulators can temporarily postpone suspensions in the interests of patients.
The CHMP’s recommendation has been sent to the European Commission for a legally binding decision valid throughout the EU.
Last year, the EMA suspended generics approved on data from contract research organisation, GVK Biosciences.
The EMA that time took action following an inspection by the French regulator, which found evidence of manipulation of electrocardiogram data, going back at least five years.
A Novartis spokesperson said: “We are working closely with our licensing partners to repeat the bioequivalence/bioavailability studies at an acceptable alternate study site.”
No-one from Teva or Mylan was immediately available for comment.
