Results of review of generic approvals with respect to potentially falsified bioequivalence studies in India.
Measures at EU level
An inspection at the research service provider GVK Biosciences in Hyderabad (India) revealed serious deficiencies in the bioequivalence studies conducted there, which serve as the basis for the approval of generic drugs. Across Europe, more than 1,000 medicines were affected. The European Medicines Agency (EMA) has completed its assessment and concluded that about 300 of these products have additional, sufficient data from other sources to provide a sufficient data basis to remain on the market.
For all other products, the EMA recommends suspension of marketing authorization(link). The final decision will be made by the European Commission soon. Excluded from the recommended suspension are those drugs that are considered critical due to the supply situation in the individual member countries. For these products the submission of further data by the marketing authorization holder within 12 months is mandatory.
Situation in Austria
The Federal Office for Safety in Health Care/AGES Medizinmarktaufsicht has evaluated the medicinal products concerned in Austria and has come to the following conclusion:
- The following medicinal products have additional, sufficient data and can remain on the market in Austria:
Nebilan 5 mg - Tablets | G.L. Pharma | 1-28256 |
Nebivolol G.L. 5 mg - Tablets | G.L. Pharma | 1-27947 |
Nebivolol ratiopharm 5 mg - tablets | ratiopharm | 1-29165 |
Venlafaxine Bluefish 75 mg - hard capsules, sustained release | Bluefish | 1-28856 |
Venlafaxine Bluefish 150 mg - hard capsules, sustained release | Bluefish | 1-28857 |
Venlafaxine Ranbaxy 75 mg - sustained release capsules | Basics | 1-31613 |
Venlafaxine Ranbaxy 150 mg - sustained release capsules | Basics | 1-31614 |
- For the following drug, the current situation still needs to be clarified between the marketing authorization holder and the EMA, as sufficient data material is available from a national perspective, but was not submitted to the EMA in time by the marketing authorization holder:
Nebivolol Genericon 5mg - Tablets | Genericon | 1-28784 |
- The following medicinal products currently do not have sufficient data and must be suspended in Austria. (note: All of these products are currently not marketed in Austria or had already undergone a voluntary supply suspension in December. As a result, no supply bottlenecks are expected).
Candesartan Arcana 4mg - Tablets | Arcana | 1-30851 |
Candesartan Arcana 8mg - Tablets | Arcana | 1-30852 |
Candesartan Arcana 16mg - tablets | Arcana | 1-30854 |
Candesartan Arcana 32mg - tablets | Arcana | 1-30855 |
Desloratadine ratiopharm 2.5 mg - melting tablets | ratiopharm | 1-31313 |
Desloratadine ratiopharm 5 mg - melting tablets | ratiopharm | 1-31314 |
Esomeprazole Arcana 20 mg - enteric-coated hard capsules | Arcana | 1-29859 |
Esomeprazole Arcana 40 mg - enteric-coated hard capsules | Arcana | 1-29862 |
Neximyl 20 mg - enteric-coated hard capsules | Arcana | 1-29860 |
Neximyl 40 mg - enteric-coated hard capsules | Arcana | 1-29861 |
It should be noted that there is no evidence of health hazards or lack of efficacy for any of the drugs involved. The recommended suspension of some products is purely precautionary. All other affected drugs that remain on the market can continue to be taken without hesitation, as there is sufficient data to maintain approval.
Further information:
EMA recommendation, Jan. 23, 2015:
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
