Falsified bioequivalence studies could lead to approval suspensions for individual generic drugs
An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious deficiencies in the conduct of bioequivalence studies for the approval of generic drugs. There is suspicion that relevant study parameters were deliberately falsified, which is a massive violation of Good Clinical Practice (GCP). This means that generic drugs of different active ingredient classes may have been approved on the basis of falsified study data, and that approval suspensions may subsequently have to be expected. The case may affect the entire EU area and other regions of the world. With regard to the Austrian pharmaceutical market, AGES Medical Market Surveillance was able to identify six marketed products that may have been approved with falsified study data.
List of products subject to further regulatory testing.
It should be noted that the present suspicious situation does not necessarily mean limited or no efficacy or side effects of the drugs concerned that deviate from the study information. The products listed above have already been in use for several years and have so far provided no evidence of poorer efficacy and safety. All preparations are drugs that have been manufactured in verified high quality and contain the same active ingredient in the same quantity as the respective comparator products (originators). Clinically relevant differences are unlikely, but cannot be completely excluded.
AGES Medizinmarktaufsicht will review the products mentioned and take any precautionary measures immediately to ensure that any future approval in Austria will continue to be based on sound studies. As the case is significant beyond the borders of Austria, further action is planned and coordinated in close cooperation with the European Medicines Agency EMA.
AGES Medical Market Surveillance is coordinating the necessary measures with the respective marketing authorization holders. Bioequivalence studies to ensure an accepted basis for approval can be performed relatively quickly in case of doubt.
In the event that the approval of one of the above-mentioned pharmaceutical specialties has to be suspended in Austria in the meantime, neither bottlenecks nor a restricted supply situation for the active ingredients concerned is to be expected according to current information.
All actions currently taken or to be taken are purely precautionary measures. AGES Medical Market Surveillance currently assumes that there is no danger to the safety of patients. However, further evaluation of the situation is absolutely necessary. It cannot be ruled out that individual approvals will be suspended in the future or that the associated products will have to be recalled.
So far, there are no indications of health hazards. The detailed evaluation of the case is ongoing at both national and European level.
Queries (technical):
Dr. Christoph Baumgärtel, Tel.: 050555/36004
E-mail: christoph.baumgaertel@ages.at
Queries (for media):
Communications Management, Tel.: 050555/25000
E-mail: presse@ages.at
