Editorials

Are generic immunosuppressants safe and effective?

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h3248 (Published 22 June 2015) Cite this as: BMJ 2015;350:h3248
  1. B Godman, senior researcher1,
  2. C Baumgärtel, senior scientific expert2
  1. 1Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden
  2. 2AGES Austrian Medicines and Medical Devices Agency and Austrian Federal Office for Safety in Health Care, Traisengasse, AT-1200 Vienna, Austria
  1. Correspondence to: B Godman Brian.godman{at}strath.ac.uk

Clinical experience is now reassuring and regulation is strict, now we need definitive evidence

Increasing use of generic drugs is essential to maintain comprehensive and equitable healthcare, given current pressure on budgets through, for instance, ageing populations. Initiatives among health authorities to promote generic prescribing include educational initiatives (which in the United Kingdom has resulted in high levels of prescribing of international non-proprietary name (INN) drugs in over 80% of all prescriptions), compulsory generic substitution in pharmacies, and patients paying extra “out of pocket” expenses for a proprietary drug.1 2 3 Concerns remain, however, about generic prescribing or compulsory substitution in certain drugs and classes of drug classes, including lithium, theophyllines, some anti-epileptic drugs, and the immunosuppressants evaluated in the linked study by Molnar and colleagues (doi:10.1136/bmj.h3163).1 4

Strict regulations govern market authorisation for generic drugs.5 Regulators such as the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) require manufacturers to show bioequivalence between a generic and a proprietary version of the same drug.6 Subsequent meta-analyses have found no difference in outcomes between generics and originators across several classes of drugs, including …

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