Over the past few months, Breakthrough Breast Cancer’s Demand a Fair Price campaign has highlighted the fact that life-extending drugs are not available to everyone with breast cancer because there is a deadlock between the drugs companies and the NHS over the high prices of these drugs. But how can this deadlock be broken?
A quick look at the history of drug development shows that once drug patents expire, generic versions come to market that are much, much cheaper. Natasha Dare, Breakthrough’s Senior Policy Officer, asks whether this model can work for important breast cancer drugs such as Herceptin, whose primary patent expired in July 2014.
Generic drugs versus biosimilars
When a pharmaceutical company markets a new drug (such as Panadol) it is normally under a patent for at least 10 years, meaning that it can only be made by the company that originally developed it. As the patent expiry approaches, other companies can start to manufacture generic versions of the drug (such as paracetamol in the case of Panadol), provided that they have exactly the same effect as the original branded version. The NHS estimates that generic medicines can cost up to 80% less than branded versions because competition increases and manufacturers don’t have to pay for development and testing.
However, several of the most effective treatments for both early and secondary breast cancer, such as Herceptin, Kadcyla and Perjeta, are biological drugs, which are produced using living cells. This produces drugs with complex chemical structures, making it nearly impossible to make exact copies. Therefore, when their patents expire, competing manufacturers can only produce biosimilars which are, as the name suggests, merely similar to the patented biological drug. Biosimilar drugs are considered to be drugs in their own right rather than generic versions of the original branded drugs.
How are biosimilars regulated?
The European Medicines Agency, which licenses drugs for use in Europe, requires manufacturers of biosimilars to show that there are no meaningful differences in quality, safety and effectiveness between the biosimilar and the original drug. Since the original drug will have been licensed in the EU for several years, this process is generally quicker than the one used to license new biological drugs. However the drugs still require some clinical studies which are expensive and time-consuming. Since 2006 more than 18 branded biosimilars have been licensed for use in the EU.
In the UK, biosimilars are already used to some extent in the NHS and it is likely that they will be used more widely over the next few years. NICE has already appraised some biosimilars and, following a recent review, has proposed that it will usually consider biosimilars when it appraises their original biological drugs. However, even once they are licensed, the safety of biosimilars is closely monitored.
So will biosimilars mean cheaper drugs?
Biological drugs are more complex to manufacture and take longer to bring to market than other drugs and so are considerably more expensive. As patents for some of the most widely used biological drugs begin to expire, biosimilars have the potential to increase access and provide lower cost options for cancer care – but will this happen?
A reasonable estimate is that biosimilars cost 20-25% less than the original branded drug, which is a much lower cost saving than for generic drugs. The main reason for this is that the regulatory barriers for these complex drugs are much higher and so manufacturers are less likely to be interested in competing to produce them.
Regardless of the costs, the potential success of biological drugs has enticed some companies to invest.For example, pharmaceutical companies have already shown some interest in manufacturing biosimilars of Herceptin. In January 2014, Biocon launched the world’s first biosimilar of Herceptin in India, and in the UK, Hospira won a 2014 court ruling overturning two patents for Herceptin, which opens the door for Hospira to begin selling its own biosimilar version.
Over time healthcare providers, regulators and patients will learn more about biosimilars, and this will probably help us accept their use in normal practice. If patients report positive experiences with biosimilars, the complex regulatory requirements for their approval and ongoing monitoring could be loosened. This would reduce the cost of producing these drugs, increase the number of biosimilars being produced and, crucially, cut the prices that healthcare providers such as the NHS have to pay.
Biosimilars might not break the deadlock today, but they might turn the key a little tomorrow – and that would be a good turn for cancer patients.
Natasha Dare is Breakthrough Breast Cancer’s Senior Policy Officer