Frequently Asked Questions
We have collected the most important and frequently asked question about our business. Please note that generics are subject to different legal definitions in different countries. The definition of generics used in this context does not make reference to any particular legal definition.For further questions, please contact our Global department
|Generics in General||Comparability and Safety||Recombinant Technologies and Biosimilars|
Are generics really as good as reference medicines?
Yes, generic medicines contain the same active ingredients and act in the same way in the human body. They may contain different non-active ingredients or differ in size, shape or color, but these differences have no impact on their therapeutic effect. The only significant difference is the price.
Are generics the same as reference medicines?
Generics contain the same active ingredients in the same concentration in the same dosage form and their efficacy is verified by strict bioequivalence studies, in which they are directly compared with the respective reference product. They may vary in their method of preparation or in the composition of inactive ingredients such as colorings or binders, which have no therapeutic effects. The only significant difference is the price.
Should I substitute a generic medicine for a reference product?
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.
How are generic medicines evaluated and compared to the reference medicine?
As the reference medicine has been authorized for several years, there is already available information about safety and efficacy. Clinical studies therefore do need not be repeated completely. However, 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.
What is a bioequivalence test?
A bioequivalence test is a clinical 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. Legislation requires these tests prior registration and authorization. Such tests prevent by law the unnecessary and unethical repetition of extensive experiments on humans and animals.
How is the safety of generic medicines evaluated and ensured?
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 install a system to monitor the safety of products that it markets. The regulators may also visit and examine the monitoring system. If specific precautions are required when taking the reference product, the generic in general has to meet the same requirements.
Is the registration procedure the same as for reference medicines?
There is no single worldwide system for the regulation and approval of both reference products or generics. In particular, separate regulatory bodies and approval processes exist in the main global markets (U.S., 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. In the United States, this principle was established in 1984 with the Hatch Waxman Act. The key elements of this act have also been adapted in other major world markets.
Do generic medicine producers have access to the (non-clinical) data of reference products?
No. In general, reference medicine data are never revealed to third parties; they cannot be used by generic producers. They must research and develop their own formulation of the product for approval. However, they may refer to published clinical data concerning the safety and efficacy of the reference product.