Q. What are generics?
Q. Are there differences between generics and the original brands?
Q. What benefits do generics offer?
Q. How can generics contribute to improving human health?
Q. Who checks the quality, safety and efficacy of generic medicines?
Q. Why is a bioequivalence test needed?
Q. Are generics really as good as the original brands?
Q. What are patents?
Q. How long do patents last on original branded medicines?
Q. Can a medicine be covered by more than one patent?
Q. What are generics?
A. Generic medicines or “generics” contain the same active ingredient as the original (reference) pharmaceutical product. They must have the same dosage form to treat the same disease as the reference medicine. Generics must demonstrate bioequivalence to show that they act in the same way in the human body as the reference product. Bioequivalence means that generics are interchangeable with the originator drug. Generics are launched when the patent of an originator product has expired.
Q. Are there differences between generics and the original brands?
A. Generics contain the same active ingredients in the same concentration and dosage forms as originator products and act in the same way in the human body. They have to comply with the same quality standards in terms of development, manufacturing, and quality control and supply conditions. They may have different non-active ingredients such as colourings, starches or sugars and may differ in shape or size. These different non-active ingredients, also known as excipients, may have a clinical effect leading to an adverse reaction.
Q. What benefits do generics offer?
A. Generics are subject to the same rigorous quality standards as the original brands and so have the same expected safety and efficacy as the reference product but at lower prices. Generics can also produce substantial savings for national healthcare systems and free up resources for more expensive treatments and services.
Q. How can generics contribute to improving human health?
A. Generics medicines cost less than originator products. Over time, competition from generics will force originators to reduce their prices after, or sometimes before, patent expiry. Therefore, generics can help increase access to medicines in developed countries struggling to contain rising healthcare costs and in developing countries which are often unable to afford branded medicines. In addition, these savings can make available resources for funding into new innovative medicines.
Q. Who checks the quality, safety and efficacy of generic medicines?
All medicines, generics and originals, have to be authorised by the European Medicines Agency (EMA) or by the national health authority [Medicines and Healthcare products Regulatory Agency (MHRA) in the UK] before they can be marketed in the European Union.
To receive marketing authorisation, generics must show bioequivalence to the originator product – meaning that all pharmacokinetic parameters are comparable to that of the original. The EMA or the MHRA assesses the bioequivalence and relies on the dossier of the original medicine as well as the results of the bioequivalence study, to infer the safety and efficacy of the generic drug.
When a manufacturer seeks registration of a generic medicine from the EMA or the MHRA, the manufacturer needs to prove that the generic compound is pharmaceutically equivalent to the original brand and through a bioequivalence study, that all pharmacokinetic parameters are comparable to that of the original.
Generics are subject to the same European procedures as originator products.
Q. Why is a bioequivalence test needed?
A. Legislation requires a bioequivalence test to be conducted before registration and authorisation to ensure the expected safety and efficacy of the generic medicine.
A bioequivalence test is a clinical study to show that the same quantity of the active substance exists in the human body whenever the same dose of a medicine, reference or generic, is taken over a certain period of time.
Q. Are generics really as good as the original brands?
A. Yes. They contain the same active ingredient in the same dose as reference products and are produced to the same rigorous quality standards, with the same expected efficacy and safety standards. Like reference products, generics are manufactured in plants that meet GMP (Good manufacturing Practice) standards and are inspected periodically by regulatory authorities. In addition, once a generic is available on the market, the manufacturer must monitor the product for any adverse events.
Q. What are patents?
A. A patent is an exclusive set of rights granted to an inventor for a limited period in exchange for making a new product publicly available. In the pharmaceutical industry, this allows only the company that developed the drug to sell it. The period of exclusivity allows the patent holder to recoup its costs and make a reasonable profit. However, once the patent has expired, generic versions of the drugs can be produced legally. The generic drug may have a patent on the formulation but not on the active ingredient.
Q. How long do patents last on original branded medicines?
A. 20 years for a standard patent, the same as in other industries. But uniquely for pharmaceutical and plant technologies, patents can be extended for a further five years in the EU by gaining a Supplementary Protection Certificate (SPC).
Q. Can a medicine be covered by more than one patent?
A. Yes. A pharmaceutical product can be covered by several patents, up to 30 or 40, to protect it against competition for as long as possible. Even if the composition of matter (the basic patent on the new chemical entity and its molecular structure), has expired, originators can extend exclusivity by extending a medicine’s indications or developing new formulations.
For further information on generic drugs
Generic Pharmaceutical Association www.gphaonline.org
And/or www.egagenerics.com
British Generic Manufacturers Association www.britishgenerics.co.uk
Last update: 04/11/2011 11:05 AM
