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. When can patients in Europe have access to generic medicines?
Q. How can you tell if a drug is a generic?
Q. How long does it take to register a generic medicine in Europe?
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. Do generic manufacturers have access to data of originator products?
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. The availability of generics means that people who may be unable to afford original medicine can receive treatment. 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 national medicines agencies before they can be marketed in the European Union.
To receive marketing authorisation, generics must show bioequivalence to the originator product - that it works in the same way in the patient’s body. The EMA or the national medicines agency 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, 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. When can patients in Europe have access to generic medicines?
A. Generic medicines can be made available to patients in the European Union only after the relevant patents on the originator product have expired.
Q. How can you tell if a drug is a generic?
A. In the European Union, generics are identified by a company name plus its International Non-proprietary Name (INN), or by its created brand name accompanied by its INN name.
Q. How long does it take to register a generic medicine in Europe?
A. It usually takes 1-2 years but sometimes longer. As with originator products, generic manufacturers have to wait for decisions on pricing and reimbursement from national authorities.
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.
Q. Do generic manufacturers have access to data of originator products?
A. No. Generic manufacturers conduct their own research and develop their own formulations as data of originator medicines are never revealed to third parties. However, generic producers can refer to published clinical data concerning the product’s safety and efficacy.
Generic manufacturers do not need to repeat clinical trials as this is unnecessary and unethical. The reference product has been authorised for several years, therefore safety and efficacy data is already available.
For further information on generic drugs
Generic Pharmaceutical Association http://www.gphaonline.org/
And/or http://www.egagenerics.com/
Last update: 7/13/2011 2:50 PM
