Q&A: Generic medicines and blood cancer
In recent weeks we’ve had some enquiries about the use of generic medicines to treat blood cancer. While generic medicines are already used to treat many types of cancer, their use for blood cancer is a fairly recent development. We asked Chris West and Reta Brownlow to answer your questions...
What does ‘generic medicine’ mean?
Developing a new medicine (drug) is an expensive process. So when a new drug is developed, the manufacturers apply for a patent. This means that they are the only company allowed to make the drug for a set period of time (usually 20 years). This process is designed to protect the company that invested in developing the drug, to make sure they earn back the money they spent on developing it.
When the patent runs out, other companies are allowed to make their own version of the drug. These versions are known as ‘generics’, ‘generic drugs’ or ‘generic medicines’. The process is often called ‘going off-patent’.
How different are generics to the original drug? Are they as safe and effective?
Generic medicines include the same active ingredient (the crucial part of the drug that treats the cancer) as the original drug, which means they act in exactly the same way. All drugs must be approved by the Medicines & Healthcare products Regulatory Agency (MHRA). A company that produces a generic version of a drug must prove to the MHRA that the generic:
- contains the same active ingredient,
- treats cancer in exactly the same way,
- is as effective,
- is the same strength and dose, and
- can be taken in the same way as the original.
However, there can be differences in non-active parts of the drug such as the substance used to coat the tablet or bind it together. You might notice that generic versions are different sizes, shapes or colours, and come in different packaging. These differences shouldn’t affect how the drug works or the side effects they can cause you.
Why are generic medicines used by the NHS?
Developing a generic drug is much simpler and quicker than developing the original drug. This means that it costs much less to develop generics, and they can be sold to the National Health Service (NHS) by the drug company at a much lower price.
As generic drugs work in the same way as the original, NHS England (the organisation that manages the NHS) publishes guidance that encourages the use of generic drugs wherever possible. It’s common practice for generic medicines to be used instead of the original ‘branded’ versions as soon as they become available. This means patients receive the same standard of care at a cheaper price for the NHS.
How are generic medicines used to treat blood cancer?
The use of generic drugs is very common in the treatment of many different health conditions. In the months and years ahead, the patents on a number of blood cancer treatments will expire and we will begin to see the use of more and more generic versions. The chronic myeloid leukaemia (CML) treatment Glivec® (imatinib) came off patent in January 2017. People who were taking Glivec® will start to receive generic imatinib when they pick up their medication.
Who decides to switch my prescription from an original drug to the generic version?
Ultimately, this decision is taken by NHS England – the organisation that is responsible for the day to day running of the NHS. They have issued guidance that generic drugs should be used as soon as they are available (as soon as the patent for the original drug runs out). They are keen that if patients can receive the same standard of care at a lower cost, this should be done as quickly as possible. Your doctor should be aware of this change and discuss this with you.
Who decides which generic is available to me?
Different drug companies will produce their own versions of a generic drug. Usually, the local Clinical Commissioning Group (CCG) or NHS Trust will make a decision about which of the generic versions will be used in your area. As the different generics all work in the same way and have the same active ingredient, the decision about which to use will often be made on financial or practical grounds – they may go for a generic which is slightly cheaper, or use a company that they already buy other drugs from, to make the payment and delivery simpler.
The important thing is that the CCG or NHS Trust will not be choosing whether one generic is better at treating cancer (more clinically effective) than another, as all generics work in the same way.
Will I be told if I’m being switched to a generic version?
Yes, your consultant should tell you and discuss this with you, so you are able to ask questions.
Will changing to a generic version affect the side effects I experience?
As the active ingredient in all original and generic versions is the same, changing to a generic version of a drug shouldn’t make a difference to your side effects. You should continue to monitor any side effects as you would with any treatment, and if you notice any changes, let your doctor know straight away.
Can I choose which version I take?
It’s very unlikely that you will be able to choose which generic version you take. Your local NHS Trust or CCG will decide which generic is being provided in your local area. One NHS area providing several different versions of the same drug would become complicated and more expensive – and as different versions of generics should all work in the way, it doesn’t make economic sense to have several different versions of the same treatment.
What are biosimilars?
You might hear some medicines called ‘biosimilars’. Most drugs are made using chemical processes to create a particular molecule which is the active ingredient, but some drugs are made using a biological process using an engineered organism.
Biosimilar drugs are generic versions of drugs made using biological processes. It’s not as easy for drug companies to make their own generic versions of these drugs because the patent holder doesn’t have to share the engineered organism with others. Instead, companies making a generic version have to create an organism themselves. This process means that the generic firm won’t be able to produce an exact replica of the original, so they are called “biosimilar” rather than simply generic.
In order to receive a license from MHRA, the company will still need to demonstrate that the biosimilar drug is sufficiently similar to the original and that patients will be able to move safely from the original drug to the biosimilar one.
Will biosimilars be used to treat blood cancers?
The patent for the lymphoma treatment rituximab, also known as Mabthera®, expired in 2016. This means that biosimilar versions of rituximab are currently being developed, and we expect them to be introduced in the NHS once they receive a licence.
What's the Bloodwise position on the use of generics and biosimilars?
Because generics and biosimilars must be able to show they treat cancer in the same way as the original drug, we support their use in the NHS. They allow patients to continue to receive the same standard of care at a lower cost to the NHS. This practice is common in the NHS in other clinical areas, and we support the use of generics in blood cancer care as the patents of original drugs start to run out.
Finding out more
If you have any questions about the use of generic or biosimilar drugs our Support Line team are here to help. Call us on freephone 0808 2080 888 (Mon-Fri 10am-4pm). If you ring outside of these hours please leave a message and we’ll get back to you as soon as possible.
Meet the experts
Chris West is Head of Policy and Public Affairs at Bloodwise. Reta Brownlow is Head of Patient Services at Bloodwise.