Developing medicines is very expensive. When a company develops a new medicine, they patent it so that other companies cannot copy it for a certain amount of time. This gives the company a chance to earn back the development cost.
After the patent protection runs out, other companies are allowed to make copies of the original medicine.
Most medicines are made by chemical processes in a laboratory. Drug companies are able to make exact copies of these types of medicine. These copies are called ‘generic’ medicines. There are generic versions of lots of chemical medicines (for example, ibuprofen).
Biological medicines are more complex medicines that are made using living sources (such as cells). Because manufacturing biological medicines involves living processes, they are much harder to copy. Even within the original brand of a biological medicine, there are slight differences between batches.
A biosimilar is a medicine that is developed to be highly similar to an existing biological medicine. Biosimilars might vary slightly from the original brand of medicine, but they work in the same way and they are equally as effective.
If your treatment for lymphoma includes a biological medicine, such as rituximab, you might be treated with the original brand of medicine or you might be treated with a different brand – a biosimilar.
Copying a successful medicine is much quicker than developing a new medicine. The original medicine has already been scientifically proven to work, so fewer clinical trials are needed for a biosimilar. As a result, biosimilars are usually less expensive than the original medicine even though the quality of the medicines is the same. The availability of biosimilars also increases competition between drug companies, which should drive costs down further.
A biosimilar goes through extensive tests in a laboratory and in small clinical trials to compare it with the original medicine. It has to match in quality, safety and efficacy (how well it works).
Then a large clinical trial is carried out in a group of people with a disease that the original is used for. This is to confirm that the safety and efficacy of the biosimilar match the original.
A biosimilar must be proven to match the original medicine, and to work as well as the original in one disease that the original medicine is approved to treat. It does not have to be tested in every disease that the original branded medicine is approved for. Instead, the manufacturer can refer to the evidence already available from the original medicine.
Once testing is complete, the manufacturing company submits the results to the European Medicines Agency (EMA). The EMA looks at the evidence and decides whether to recommend that the biosimilar medicine is approved for use in Europe. If so, it is then approved in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).
Watch the EMA's animation explaining how biosimilars are approved in Europe.
During the transition period of the UK’s withdrawal from the EU, the UK is following the EMA’s approval process. At the time of writing, it is not clear how the approval process will be affected when the transition period ends on 31st December 2020.
In most cases, if the original biological medicine is available on the NHS, any biosimilar that is approved by the EMA and MHRA will also be available on the NHS.
At the time of writing, the only biosimilar medicines approved to treat lymphoma are rituximab biosimilars.
Rituximab is a biological medicine that is widely used to treat people with non-Hodgkin lymphomas that develop from B lymphocytes (B cells). It is used on its own or with other medicines to treat lymphoma. The original brand of rituximab is called MabThera. Rituximab biosimilars include Truxima and Rixathon. Other brands might become available.
Rituximab biosimilars that are given through a drip into a vein (intravenously) have been available in Europe since 2017. Different brands of rituximab have different trade names. They have all been tested to make sure they match the original brand in quality, safety and efficacy.
Talk to your medical team if you have a question about biosimilars that isn’t answered here or you are worried about switching to a biosimilar.
What brand of rituximab will I have?
The brand of rituximab you have depends on which brand your hospital stocks. This in turn depends on what arrangements they have with the manufacturing companies. They are likely to choose the most cost-effective option.
Brands of rituximab that are available include MabThera (the original brand), Truxima (a biosimilar) and Rixathon (a biosimilar). All brands of rituximab are equally effective at treating lymphoma.
Your medical team can give you more information about your brand of rituximab, including the patient information leaflet.
Will I be switched from the original brand to a biosimilar?
If you are being treated with a biological medicine, your doctor should prescribe you with a named brand. You can't be switched to a different brand (a biosimilar) unless your doctor changes your prescription.
If your doctor plans to switch your brand of medicine, they should discuss this with you. This might happen if, for example, a new biosimilar becomes available, or if your hospital or pharmacy decides to change the brand of biological medicine they stock. Since biosimilars work in the same way as the original biological medicine, you should not notice any difference in the effects the new brand of medicine has on you.
Your medical team should be able to answer any questions you may have about switching brands.
What should I do if I have any problems?
You are monitored in exactly the same way regardless of which brand of medicine you have. If you experience problems with any treatment, report these promptly to your medical team.