What is Generic Medicines/Generic Drugs

Generic Medicines: Equivalent versions of trusted medicines

A generic medicine is an equivalent of an originator pharmaceutical product. It contains the same active substance as, is “essentially similar” to, and is therefore interchangeable with, the originator product.

A generic medicine is marketed in compliance with international patent law. It is identified either by its internationally approved non-proprietary scientific name (INN) or by its own brand name. Generic medicines are widely used in many EU countries in cost-effective treatment programs, and are increasingly prescribed by doctors as effective alternatives to higher-priced originator pharmaceuticals.

Generic Medicines: Quality medicines at affordable prices

A generic medicine provides the same quality, safety and efficacy as the original brand name product and undergoes strict scrutiny before it is licensed and given market approval by the European or national medicines authorities.

A generic medicine is typically 20% to 90% less expensive than the brand-name original. In addition, the availability of lower-priced generic medicines brings down the price of originator drugs through market competition, producing even further savings to patients. The use of generic medicines saves European patients and healthcare systems an estimated €25 billion each year.

Generic Medicines: A tradition of excellence

In order to maintain strict national, European and international regulations, the EGA encourages the production of pharmaceutical ingredients and medicinal products to the highest standards of excellence. All the individual companies represented by the EGA produce in accordance with the rules of Good Manufacturing Practice (GMP) in approved and regularly inspected plants. Once a generic medicine has been approved for use by patients, its use continues to be monitored closely by the manufacturer and the health authorities. In short, generic medicines comply with the same strict standards of quality, safety and efficacy as original pharmaceutical products.

Generic Medicines: Strict observance of bioequivalence

The key factor in creating a generic medicine is establishing bioequivalence. Bioequivalence means that, when compared scientifically, the generic medicine and the originator product demonstrate essentially the same rate and extent of biological availability of the active substance in the body when administered in the same dose. In simple terms, the generic medicine and the original product must be equally effective.

Generic Medicines: Benefiting society

In an era when increasing demands are being made on Europe’s healthcare services, generic medicines provide a major benefit to society by ensuring patient access to quality, safe and effective medicines while reducing the cost of pharmaceutical care. The estimated €25 billion in savings each year help provide national healthcare systems with the budget headroom needed to deliver more expensive medical treatments and services that patients often need.

Generic Medicines: Bringing economic sense to pharmaceutical care

Increasing the availability and range of generic medicines on the European market is essential for pharmaceutical care. Allowing effective competition between generic medicines and patent-expired original brands is crucial to lowering pharmaceutical costs and stimulating innovation.

Generic Medicines: Contributing to growth and employment

The European generic medicines industry operates advanced research laboratories and production plants run by highly skilled personnel. Companies typically invest 6-16% of their revenues (and in some cases up to 30%) into researching and developing new products. In a number of EU countries, EGA companies are major providers of the medicines used in the healthcare market. In addition, European manufacturers are the world’s leading exporters of quality generic active ingredients, thus making a positive contribution to Europe’s trade balance in pharmaceuticals.

Generic Medicines: Committed to the future

Ageing populations and rapidly rising treatment costs are causing governments throughout the world to look again at the sustainability of their healthcare provision. Economically priced generic medicines provide a cost-effective means of controlling the fastest growing budget item in healthcare: pharmaceuticals. The EGA and its members will continue to work with the EU Member State governments and the EU institutions to develop affordable solutions for pharmaceutical care and to enhance Europe’s competitive position in the global pharmaceuticals market.

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Pradeep Agarwal

Marketing - AstraZeneca
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