title: Generics: keep a balanced view.
abstract: Once the different kinds of commercial protection (patents, etc.) granted to the manufacturer of an "originator" drug have expired, the drug in question may be copied by other companies. These copies are known as generics. The characteristics and pharmaceutical quality of generics are governed by international standards. The marketing authorisation procedure for generic drugs dispenses with preclinical and clinical trials, which already exist for the originator drug. In contrast, proof of bioequivalence must be provided. In practice, this means demonstrating that the effects of the generic are similar (but not necessarily identical) to those of the originator drug. Slight differences between a generic and its brand-name counterpart are allowed, provided they do not markedly affect the efficacy or adverse effect profile in comparison to the originator drug. The accepted degree of difference between a generic and the original brand-name drug is the same as the acceptable difference between two batches of the originator drug. The rules governing generic manufacturing conditions are identical to those applying to originator drugs. And issues raised by drug production abroad, particularly to Asian countries, apply to originator just as much as to generic drugs. Generics represent a significant source of financial savings for society. In France, various measures have been introduced to encourage doctors, pharmacists and patients, respectively, to prescribe, dispense and use generics. Criticisms of the efficacy or quality of generics are often unfounded and sometimes deliberately orchestrated. Smear campaigns conducted by drug companies that market originator drugs, and also by some healthcare professionals, sow confusion, to the detriment of generic use. There is no tangible proof that generics are less safe than originator drugs, provided they are chosen wisely, taking into account factors such as their packaging quality. It is up to healthcare professionals to decide when a generic is appropriate. Ideally, the doctor should prescribe using the international nonproprietary name (INN), leaving it up to the pharmacist to choose the generic best suited to the patient.
mesh_terms: D017046:Cost Savings; D016568:Drugs, Generic / Q000009:adverse effects* / Q000191:economics; D006801:Humans; D010595:Pharmacists; D060735:Pharmacovigilance; D013810:Therapeutic Equivalency
chemical_list: D016568:Drugs, Generic