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"The provision of quality drug treatment at affordable prices to all people across the globe in a manner that supports sustainability"

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What is a generic medicine?
A generic medicine contains the same active ingredient as the originator medicine on which it is based. It offers the same high quality and efficacy, together with affordability. This combination has made them increasingly attractive for healthcare systems. They can be marketed after the patent expiry of the originator product on which they are based.

 
Why are generic medicines regarded as equivalent to originator medicines?
Generic medicines contain the same active ingredient as the originator medicines on which they are based. They are subject to the same authorization process and can only qualify for authorization if they are "bioequivalent" to the originator medicine.

 
What is bioequivalence?
Bioequivalence means that, when compared, the generic medicine and the originator medicine demonstrate the same rate and extent of biological availability of the active substance in the body when administered. In simple terms, the generic and the original medicine must be equally effective.

 
What is a supergeneric drug?
These tend to be “high-barrier-to-entry generic products,” or specialty generic pharmaceuticals. They differ from the original product in formulation or method of delivery. At Medochemie, a good example of a supergeneric is our dry powder inhalers which involve an innovative method of delivery.

 
What are the advantages of generic medicines?
The main advantage of generic medicines is that they cost considerably less. In an era when increasing demands are being made on healthcare services, generic medicines provide a major benefit to society by ensuring patient access to quality, effective and safe medicines while reducing the cost.  Moreover, competition from generic medicines encourages originator medicines to lower their own prices, and develop new, patentable products.

 
In what therapeutic areas are generic medicines used?
Generic medicines are based on originator medicines thus they can treat exactly the same condition with the same high level of quality, efficacy and safety, at a lower cost. Some therapeutic areas were generic medicines are used, include: high blood pressure, diabetes; depression; Parkinson's disease; Alzheimer's disease; osteoporosis; and cancer; HIV/Aids. Generic medicines are therefore used across the entire healthcare spectrum.

 
How are generic medicines evaluated and compared to originator medicines?
As the originator medicines have been authorized for several years, there is already available information about efficacy and safety. Clinical studies therefore do not need to be repeated completely. However, legislation defines tests to ensure that the generic medicines are equally effective and safe – usually though a bioequivalence study. Manufacturing standards for generic medicines are the same as for any other authorized originator medicines.