At Sandoz, we verify the efficacy of our generics by thorough bioequivalence studies and are confident they meet the highest quality standards. However, we believe in open communication and recommend that you consult your doctor or pharmacist before making any changes to your medication. Your health professionals will then be able to give you the best care at the best price.07-12-2007

As with any other medicine, a generic must receive marketing authorization. This is granted after a regulatory authority, for instance the FDA in the US, has scientifically evaluated the efficacy, safety and quality of the medicine. Reference medicines benefit from a legally defined period of data protection. Once this period ends, companies may apply for marketing authorization for generic versions of the medicine.07-12-2007

As the reference medicine has been authorized for several years, there is already available information about safety and efficacy, which means that clinical studies need not be repeated in full. The legislation defines tests to ensure that the generic is equally safe and effective – usually a bioequivalence study. Manufacturing standards for generics are the same as for any other authorized medicine and regulatory authorities perform similar periodical inspections of manufacturing sites.07-12-2007

A bioequivalence test is a study to show that there is the same quantity of the active substance in the human body whenever the same dose of the reference or generic medicine is taken over a defined period or periods of time. Such tests prevent by law the unnecessary and unethical repetition of extensive experiments on humans and animals.07-12-2007

The safety of all medicines, including generics, is evaluated during the registration procedure by the competent authorities. Monitoring activities also continue after authorization. Each company is required to set up a system to monitor the safety of products that it markets. The regulators may also inspect the monitoring system. If specific precautions are required when taking the reference product, the generic will generally have to meet the same requirements.07-12-2007

There is no single worldwide system for the regulation and approval of medicines, be they reference products or generics. In particular, separate regulatory bodies and approval processes exist in the main global markets (US, Europe and Japan) as well as in other countries. The main difference is that generics do not need to go through the same full clinical trial programs, because their therapeutic equivalence has already been demonstrated, for instance by a bioequivalence study. To take the example of the US: This principle was established in 1984 by the Hatch Waxman Act. The key provisions of this act have also been adapted in other major world markets.07-12-2007

This depends on the market, but certain basic principles usually apply. In the EU, for instance, a generic medicine is identified either by a company name plus its International Nonproprietary Name (INN) or by its own invented brand name.07-12-2007

International Nonproprietary Names (INNs) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name can be used as a generic name.07-12-2007

The 1984 Drug Price Competition and Patent Term Restoration Act of 1984 is commonly known as the Hatch Waxman Act. On the one hand, it introduced a five-year period of data exclusivity for innovative medicines in the US. On the other hand, it simplified the approval process for generics. In particular, it established the US procedure for Abbreviated New Drug Applications (ANDAs), and was thus in many ways the trigger for today’s generics industry.07-12-2007

Yes, an application for a generic medicine can be started after the end of the data protection period of eight years. However, the original – reference – medicine still has another two years of market exclusivity. This period can be extended to three years in total if, for instance, an innovative further indication has been achieved within the first eight years. Patents are handled independently from the data protection period.07-12-2007