It will come as no surprise to pharmacists that infliximab biosimilars have been shown to be as safe and efficacious as the originator product – this, after all, is the basis on which they are approved in the first place. However, there has been much confusion about biosimilars and many calls from clinicians for comparative studies. Many column inches in this journal have been devoted to the unfolding biosimilars story and the position was recently summarised in a report of the 2016 EAHP Congress (see Hospital Pharmacy Europe issue 82).
A recent audit carried out by the Royal College of Physicians (RCP) in the UK examined the use of biological therapies in inflammatory bowel disease (IBD). It included 3000 patients who had started treatment in the 12-month period up to February 2016. It is the first such audit to be undertaken since the introduction of the biosimilar versions of infliximab (Inflectra and Remsima).
The authors noted that their findings show that infliximab biosimilars are as effective as the originator product (Remicade). Other key findings were that patients continue to benefit from receiving biological therapies and that such therapies are being adopted earlier in the treatment of patients with IBD. In addition, the frequency of surgery prior to treatment has reduced (from 36% of adults in 2011 to 15% in 2016). Patients are also reporting improvements in their health and quality of life after starting treatment.
Among other things, the report recommended that clinicians should use infliximab biosimilars as the first line anti-TNFa agent for appropriate patients with active IBD. The biosimilar products are considerably cheaper than the originator product and it is estimated that their use could reduce the cost of treatment from approximately £10,000 per patient per year to less than £5000. Savings of a similar order (€6000 per patient per year) were made when biosimilar infliximab was introduced in Norway in 2014.
Now that the RCP – in association with the Royal Pharmaceutical Society, the Royal College of Nursing and other bodies – has officially endorsed the use of biosimilars, it should be easier to introduce them into routine practice. However, there remain important tasks to be done to ensure continued effective use of the products. The audit also found that improvements were needed in pre-treatment infection screening and post-treatment monitoring.
Only 60% of adult and 47% of paediatric patients audited had complete pre-treatment screening for opportunistic infections; moreover, only 31% of adult and 44% of paediatric patients were recorded as having been followed up at three months.
Furthermore, clinicians should audit all patients on biological therapies to ensure their safe and appropriate use. This cannot be over-emphasised – last year one audit (of IBD patients receiving biologics through homecare services) showed that about two-thirds of the patients could have their treatments discontinued (in accordance with National Institute for Health and Care Excellence guidelines) and deliveries to one patient continued for several months after his death. These are all areas where a pharmaceutical input would be appropriate and helpful – another step in the drive for medicines optimisation.
The RCP audit has presented some valuable and welcome findings – less surgery and greater wellbeing is a good thing all round and a good reminder that biosimilars are safe and effective and have just become much more affordable. We stand by to see what the next wave of biosimilars will bring.