Branded versus generic medicines: is there any difference?

By Colin Cable, Pharmaceutical Science Information Adviser

Medicines have undoubtedly made a huge difference to the lives of millions of people.

But why do some medicines have more than one name?

When a medicine containing a new drug molecule first becomes available, the pharmaceutical company usually sells it under a brand name. Pharmaceutical companies take out a patent which gives them exclusive rights on each new drug they discover for up to 20 years. However, it can take up to 15 years from discovering a new drug molecule to its marketing as a medicine at a cost estimated to be up to £1 billion. Of a total patent life of 20 years, a pharmaceutical company may have as little as 5 years patent life remaining to recoup all the costs involved in getting the medicine to the market.

Once a patent expires on a new medicine, generic medicines companies can begin to apply to produce their own versions. For example, the generic name of a drug used to treat diabetes, is metformin, while a brand name for metformin is Glucophage.

But are generic medicines, which are usually much cheaper, as good as branded medicines?

The main reason generic drugs are cheaper is because the manufacturers have not had the expenses of discovering, developing and marketing a new drug. The substantial money invested in research, development and marketing has already been spent by the manufacturer of the initial branded medicine.

Regulatory authorities who license medicines strictly control generic medicines to ensure they are equivalent to the branded product.  Generics must contain the same drug at the same strength, the same dosage form e.g. be a tablet, and given by the same route of administration e.g. taken orally, as the branded product. They must deliver the same amount of active drug and at the same rate as the branded product, thereby producing the same therapeutic effect. However, the colour, shape, flavour and inactive ingredients of generic medicines may differ.

When buying over-the-counter (OTC) medicines, it is not unusual for several branded as well as generic products to be available. All OTC medicines are subject to the same regulatory authority controls, and the use of a brand name for many OTC products is generally done for marketing, advertising and brand loyalty purposes.

In very rare cases it will be important for a patient to stay on a branded medicine, such as where small changes in drug absorption can have clinical effects in patients, or for some modified release products. For example, patients taking oral ciclosporin, a drug used to suppress the immune system, should always have their medicine prescribed by brand name, otherwise there can be clinically significant changes in the drug level in the blood.

In summary, the steps involved in licensing generic medicines ensure they are made to the same high standards as branded products. They have the same levels of safety and quality as branded products and produce the same therapeutic effect.

I want people to make informed decisions about the medicines they use over the counter or on prescription, be they branded or generic. The best way to do this is to speak to your pharmacist about your medicines for expert advice.

Watch RPS Chief Scientist Professor Jayne Lawrence giving expert opinion on over the counter painkillers in a report on BBC 1’s Watchdog.