Parliament Reviews Patient Risk & Biosimilar Medicines
07/11/2007 - 07/11/2007
Parliament Reviews Patient Risk & Biosimilar Medicines
In early November, Parliamentarians met to examine issues surrounding the imminent availability of copies of innovator biotechnology medicines in the UK, so called ‘biosimilar’ medicines. Other European countries, such as Spain and France, have implemented laws to ensure safe and effective use of biosimilar medicines. However, no such measures have been adopted in the UK. The Parliamentarians considered the issues and made recommendations that will go to Government.
Biotechnology medicines, or medical treatments derived from biotechnology, have been revolutionising cancer care and have brought significant benefits to cancer patients*. When these medicines have been available for some years and their patents expire, other companies may try to make copies, called ‘biosimilars’. ‘Biosimilars’ are medicines which are similar to the original medicine, but due to the complexity of biotechnology medicines they are not an identical copy. Biopharmaceutical medicines are large and complex and there is no guarantee that a ‘biosimilar’ will work in exactly the same way as the original medicine. Even small differences between the innovators medicine and the ‘biosimilar’ may potentially have significant clinical effects. For this reason the European regulators impose commitments on the manufacturers of biosimilar medicines to ensure that they collect additional safety information. It is therefore important that the prescribing doctor in the UK is in control and knows whether the originator or the‘biosimilar’ medicine has been dispensed.
On 7th November, a number of eminent Parliamentarians, all with extensive health-related experience, met in the House of Lords to review how the Government should address the pressing concern of the imminent availability of ‘biosimilars’ in cancer treatment. The panel was chaired by Dr Brian Iddon MP, a chartered chemist, who has previously shown an interest in Rarer Cancers; Dr Doug Naysmith MP; Dr Des Turner MP; Lord Walton of Detchant and Lord Rea who hosted the event.
Speakers with expertise in the area gave evidence to the panel. These speakers included Professor Nick Bosanquet of Imperial College, who discussed how health policy could be amended to protect patients; Professor Neiderweiser of Leipzig University, who discussed the German approach to managing ‘biosimilars’, where they also have concerns regarding the automatic substitution of biosimilar medicines; Dr Fluck, a haematologist from Derby Hospitals who discussed the clinical concerns and perspectives of treating patients with ‘biosimilar’ medicines and Katherine Murphy of the Patients Association, who raised the importance of patients being fully aware of whether they are receiving an original or biosimilar medicine.
These expert witnesses stressed that it was too soon to know exactly how ‘biosimilar’ medicines might affect patients and certain actions should be taken to ensure patient safety, such as: ensuring prescription of biotech medicines by brand name alone; the urgent ban on the automatic substitution of originator medicines with ‘biosimilars’; a patient safety campaign on the potential risks related to substitution of biotechnology medicines and requirements for patients to report Adverse Drug Reactions.
* Examples include the vascular endothelial growth factor inhibitors that are currently used for treating colorectal cancer, proteosome inhibitors that are used for treating multiple myeloma and the erythropoietins that are licensed for treating anaemia resulting from the use of chemotherapy.
The full verbatim of the report will be available shortly from Amanda@insightpa.com
