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.
Generics are subject to the same rigorous quality standards as the original brands and so have the same safety and efficacy as the reference product. Generic drugs are usually provided at significantly lower prices than their branded equivalents. They may also receive the benefit of the previous marketing efforts of the brand-name company. Therefore, generics can produce substantial savings for national healthcare systems and free up resources for more expensive treatments and services.
In general, generics medicines cost less than originator products. Over time, competition from generics will lead to the decrease of the price of the drug making it affordable for a larger number of patients. Therefore, generics can help increase access to medicines in developed countries struggling to contain rising healthcare costs and in developing countries that are often unable to afford branded medicines. In addition, these savings can make resources available for funding new innovative medicines.
Legislation requires a bioequivalence test to be conducted before registration and authorization to ensure that the generic medicine is identical to the original product with respect to pharmacokinetic and pharmacodynamical properties. 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.
All medicines, generics and originals, have to be authorized by the European Medicines Agency (EMA) or by the national health authority [e.g. Medicines and Healthcare products Regulatory Agency (MHRA) in the UK] before they can be marketed in the European Union. In other countries they have to be approved by national health authorities such as FDA in the USA, ANVISA for Brazil and the FDA for China. When a manufacturer seeks registration of a generic medicine from a health authority, the manufacturer needs to prove that the generic compound is pharmaceutically equivalent to the original brand in terms of safety and quality and through a bioequivalence study, that all pharmacokinetic parameters are comparable to that of the original.
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. Once a generic product is available on the market, the manufacturer must monitor the product for any adverse events. This process is the same as for original products.
The generic product needs to have proven bioequivalence with the original brand. The development, formulation and manufacturing has to be described in detail. The manufacturer has to prove high standards of quality systems in place. The same quality standards as those for original brands are requested for manufacturing of the active ingredients and the final dosage form, for packaging and testing of the final product. The approval process usually takes 10 to 36 months.
No differences with respect to quality, safety and efficacy are allowed. Some differences with respect to pharmaceutical features such as color, shape or marking are acceptable, as far as they do not influence quality of the products. The largest differences are with respect to the cost of treatment.
A patent is a government authority or license conferring a right or title for a set period, especially the sole right to exclude others from making, using, or selling an invention. 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 of research and development 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.
Twenty 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).
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 generating new evidence and extending a medicine’s indications or developing new formulations.