GENERICS
New report emphasises cost savings of generic drugs
THe COsT sAVINGs OF GeNeRIC DRUGs HAVe BeeN LONG ReCOGNIseD, BUT A NeW RePORT HAs ONCe AGAIN eMPHAsIseD HOW MUCH THe PResCRIBING OF GeNeRIC DRUGs CAN BeNeFIT THe NHs…
W
hen a branded drug loses its patent protection, the market is awash with
generic equivalents from a wide range of manufacturers. Generic drugs are drugs that contain the same chemical substance as a drug that was originally protected by a patent. As soon as the patent expires (usually after ten years), generic drugs become available.
Generics are authorised to the same standards of safety, quality and efficacy as the original branded drug. The only ways in which the generics differ from the original branded drug (and indeed from each other) is in terms of colour, taste and packaging.
Before going to market, generic drugs have to undergo clinical studies to prove that they are totally bioequivalent to the original product and, even more importantly, that they deliver equal benefits for patients.
The cost-saving benefits that generic drugs bring to the United Kingdom’s National Health service are obvious – and welcome. Indeed, on its website, the British Generic Manufacturers Association says that ‘a key feature of the strong generics industry in the UK is that it introduces competition to the supply of prescription medicines, making them more affordable to the NHs and enhancing their availability to patients.
According to the NHs’ own figures, more than a billion items are prescribed generically every year in the UK. The increase in generic prescriptions, in conjunction with a
12 - PHARMACY IN FOCUs
reduction in the net ingredients costs, means that overall savings to the NHs medicines bill are now in excess of £13 billion annually.
In the UK, market prices for generics are set with no barriers to entry other than that the product gains its marketing authorisation based on its safety, quality and efficacy The and the prescribing of generics is encouraged at all levels.
Indeed, GPs in the UK are trained at medical school to write prescriptions by a drug’s generic name or International Non-proprietary Name (INN), unless there is a clinical reason for prescribing the branded version. Hospital trusts also encourage their GPs to do likewise.
India is another leading country in the world’s generic drugs market, exporting $17.3 billion (Us dollars) worth of generic drugs to both the UsA and the UK.
The UsA is a great advocate of generic drugs. In 2012, 84 per cent of prescriptions in the UsA were filled with generic drugs, while, in 2014, this figure had grown to 88 per cent of the 4.3 billion prescriptions, leading to $254 billion in healthcare savings.
Not all countries in europe are quite so open-minded in their attitude towards generics, however. Many countries, for example, base the cost of their generic medicines on the price of the equivalent branded drug or through other forms of reference pricing.
This approach certainly stifles competition and reduces the number of companies in the market, not only leading to an increased risk of medicines shortages, but also affects competition in terms of generic drug prices.
Once generics enter the market, competition often leads to substantially lower prices – both for the original brand-name product and also for its generic equivalents.
The competition between these manufacturers is intense, and, as a result, often drives prices down, sometimes by more than 90 per cent within a few weeks: great news for organisations like the NHs.
A new report from America’s Food and Drug Administration (FDA) has also shown that greater competition among generic drug makers is also associated with lower generic drug prices.
The FDA report, which is drawn from two different sources, shows that, for products with a single generic producer, the generic average manufacturer price (AMP) is 39 per cent lower than the brand AMP before generic competition.
Once two competitors are involved, however, AMP data shows that generic prices are 54 per cent lower than the brand drug price before generic competition, creating even greater savings.
EMA recommends approval for two new generics
The european Medicines Agency’s (eMA) human medicines committee recently recommended two new generic drugs for approval: clopidogrel/acetylsalicylic acid and deferasirox.
Clopidogrel is an antiplatelet drug used to reduce the risk of heart disease and stroke. When combined with aspirin (acetylsalicylic acid), it can be used to treat myocardial infarction and following surgery to place a stent in a coronary artery. A recent study found that generic clopidogrel is equally effective as the originator drug (marketed as Plavix) in the treatment of patients with acute coronary syndrome. The eMA-recommended generic is produced by generics giant Mylan.
The second recommended generic, deferasirox, is an iron chelator used to reduce levels of excess iron in patients receiving long-term blood transfusions for chronic anaemias, such as the genetic disorder �- thalassemia. The generic version has been produced by UK-based drug maker Accord Healthcare.
Accord also recently received eMA approval for two generic drugs based on posaconazole, which is an antifungal medicine used to treat a range of fungal infections. The generics are both copies of Noxafil, which has been sold in the european Union since 2005.
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