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Frequently Asked Questions

What is a reference drug?

A reference drug is originally discovered and developed by a pharmaceutical company. In order for the company to market and sell its product it must first gain approval from the relevant authorities by submitting a new drug application. In this documentation the company submits data to establish clinical safety and efficacy. Other studies determine the characteristics of the drug dosage form, including the manufacturing process, drug stability, purity, strength, and how it dissolves. Once the drug receives its approval, the company can then exclusively market and sell it for as long as the company has patent protection.

What is a generic drug?

A generic drug is a copy of a reference drug whose patent has expired. Once that patent-protected time has passed, any other company can manufacture and sell a drug with the same ingredients as the reference one. The competent authority (The FDA or the Syrian Ministry of Health) considers a generic drug to be identical to a reference drug. Generic drugs are copies of reference drugs and have exactly the same dosage, intended use, effects, side effects, route of administration, quality, risks, safety, strength and have demonstrated bioequivalence. In other words, their pharmacological and therapeutic effects are exactly the same as those of their reference counterparts.

Why do medicines have sometimes more than one name?

A medecine has a generic name, which is the active ingredient of the medicine, and a brand name, which is the trade name the manufacturer gives to the medicine. The brand name is chosen by the manufacturer, usually on the basis that it can be easily recognized, pronounced and remembered. Glyciphage for example is the brand name given by Bahri Pharmaceuticals to the generic medicine Metformin.

What is an under licensed product?

An under licensed product is manufactured by a pharmaceutical company for another company besides their own products. Under licensed products may be reference drugs that are still under patent or generics for which a license has been granted to a local/regional manufacturer to produce.

What are patents and why do they expire?

A patent is granted to the company that developed the drug and gives it the exclusive right to sell the drug for as long as the patent is in effect, which may last for 20 years. As the patent nears expiration, other manufacturers can apply to the competent authority for permission to make and sell generic versions of the drug. Patents serve public interest by giving a temporary monopoly to inventors of new products in return for developing a new drug and sharing their knowledge with the broader scientific community.

What are the advantages of generics?

The big advantages that generics provide are economic benefits: they're much less expensive. Generics can cost from 20% to 90% less than the price of reference medicines. The reason of their significant lower prices is that initial basic and clinical research programs do not need to be repeated in full for their development and these cost savings are passed on to patients.

Generic drugs make needed medicines widely available to populations that could not previously afford them.

Are generics as good as references?

Yes they are. The relevant authority requires that generic drugs be as safe and effective as reference drugs. Moreover, the generic drug manufacturer must ensure that the drug they are producing contains the same active ingredients as the reference product, in the same dosage form, at the same dose or concentration, and for the same route of administration. The relevant authority also requires that generic drugs efficacy is verified by bioequivalence studies, in which they are directly compared with the respective reference products.

What is the difference between generic drugs and reference drugs?

The major difference between a reference pharmaceutical and its generic counterpart is neither quality nor efficacy. The drugs may differ in color, shape, taste,  inactive ingredients, and packaging, all which have no therapeutic effect. They are also cheaper than reference drugs because they have much lower development costs as the manufacturer doesn't need to invest in the clinical and development research programs.

How is the safety of the generics evaluated?

The relevant authority requires tests to ensure that generic drugs are as safe and as effective as the original reference products, usually a bioequivalence study. The generic drug manufacturers are also required to prove to the authorities that their product is manufactured in accordance with good manufacturing practices (GMPs), and is as pure and stable as the brand-name product.