Generics medicines: a tradition of quality, safety & efficacy.
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Generics: Guaranteed Quality, Safety and Efficacy
For generic medicines, as with all pharmaceutical products, scientifically controlled quality is of paramount importance. Generics producers seeking marketing approval in the EU must comply with stringent rules and regulations ...
Stringent rules
For generic medicines, as with all pharmaceutical products, scientifically controlled quality is of paramount importance. In order to prove the quality of their products, all pharmaceutical producers seeking marketing approval in the EU must comply with stringent rules and regulations, including the submission of detailed documents to the competent authorities. These documents must contain:
- a full composition of the medicinal product (i.e. active substance and excipients);
- a description of the manufacturing method;
- a description of the control methods employed by the manufacturer;
- results of pharmaceutical tests on the active substance and the finished product (1) ;
- a recent manufacturing licence and certificate of Good Manufacturing Practice (2).
Bioequivalence testing
Since, generic medicinal products contain well-known, safe and effective substances, it is not necessary to repeat pre-clinical tests and clinical trials. Instead, these are replaced by what are known as "bioequivalence studies" or simply "biostudies".
The biostudy is of great importance as it demonstrates therapeutic equivalence between the test product and the originator product used as a reference. The generic medicine and the reference product are considered to be bioequivalent (and therefore interchangeable in treatment) when the bio-study demonstrates that these two formulations have no significant differences in the rate and extent of absorption in the human body (3).
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Preventing unethical repetition of tests on humans & animals
The biostudy is also important because it prevents by law the unnecessary and unethical repetition of extensive experiments on humans and animals whilst still guaranteeing that generic medicines have the same quality, safety and efficacy profile as originator medicines. Indeed, requiring the repetition of trials to prove facts already known would be in breach of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
Generic quality is a well-established fact
The pharmaceutical quality and therapeutic equivalence of generic medicines is well established by the medicines authorities during the authorisation procedure, as demonstrated by extensive testing and documentation, and often by years of practical experience in treatment. Patients and policy-makers should be cautious of misleading information which would indicate the contrary. Indeed, the variation between different batches of an originator product is often of the same magnitude or even greater than the statistically calculated and controlled difference between a generic medicine and its reference product (4).
(1) For example, molecular identity, dissolution rates, levels of impurities, and chemical stability of the product.
(2) GMP ensures that products are produced consistently and controlled to stringent standards of quality. To be GMP certified a company must show that it maintains appropriate facilities and equipment, properly trained staff, approved procedures, detailed manufacturing records, and suitable storage and transport capabilities.
(3) The test would involve comparing the same dose under the same conditions. There are very strict criteria for bioavailability studies, including i) detailed prior-determination of the experimental system, ii) submission to and approval by an ethics commission, iii) sufficient number of test persons (volunteers), iv) thorough medical examinations of the test persons before and after the study, v) cross-over design of the study, vi) standardised study conditions, and vii) sufficient “wash-out” periods.
(4) (Meth. Find Exp. Clin. Pharmacol. 1989; 11:647-655)