EU debate on biosimilar drugs

by Brian Kennedy and David Charles
Published in the Hippocratic Post, November 15, 2016

Biosimilar medicines have been the hot subject of debate for a number of years. But as health systems around the world face continued budget squeezes and seek to increase the number of patients treated with biosimilars, the use of these less expensive options becomes ever more pertinent.

Today (Tuesday 15th November) patient groups from across Europe are coming together in the EU Parliament to voice their concerns about biosimilars – of which 21 have so far been approved across the EU, with many more planned in the future. The rallying call is being led by our organisation – the Global Alliance for Patient Access (GAfPA) – an international network of physicians that advocate for patient access to approved therapies – and the European Federation of Crohn’s and Colitis Association’s (EFCCA). More than 70 groups, representing patients with chronic illness across rheumatology, gastroenterology and dermatology will discuss issues of patient access and safety with MEPs and European policymakers, before deciding how best to work together to ensure that patient choice – and their voice – is not drowned out in by the need to reduce healthcare spending.

What are biosimilars?

Biosimilars are products that are ’highly similar’ to – but not exact copies of – a biological medicine (which is often known as the ‘reference’ or ‘originator’ biologic). First introduced in the 1980s, biologic medicines now used by over 350 million patients have revolutionised the treatment of a range of diseases, including multiple sclerosis, inflammatory bowel disease, psoriasis, and cancer. However, as patents expire for originator biologics, companies are now creating biosimilars – which are usually less expensive than the original medicine.

Physician concerns around biosimilars

As a network of physicians and patient advocates, GAfPA welcomes the opportunity that biosimilars provide for more choice in the treatment of patients. But this enthusiasm for new and often less expensive medicines must not overshadow key questions which remain about the safe and appropriate use of biosimilars, particularly for patients that are switched to them having already been successfully treated with an originator biologic.

GAfPA strongly believes that patients and physicians must be central to any decision on switching, as it is ultimately the patient’s wellbeing that may be impacted by any adverse effects – be that a drug reaction, harmful immune response, or lack of efficacy. We know that patient groups share this view. Over the past year GAfPA has hosted a number of workshops across Europe with patient advocacy groups on the subject of biologics and biosimilars – including Barcelona in February, in conjunction with EFCCA, with over 60 patients with immunological conditions, as well as a meeting of Nordic patient advocates in Copenhagen in October. At every turn, patients have overwhelmingly raised their concerns with us about the impact of switching patients to a biosimilar, especially those who have worked with their physician to become stable on their current treatment. Patients are also worried about the lack of information given by physicians intent on switching patients, the lack of adequate tracking and tracing of biologic and biosimilar medicines in the case of adverse events, and how physicians go about ensuring there is meaningful and informed patient consent when deciding to switch a patient to these new medicines.

The evidence base for switching to biosimilars

The evidence base to support the prescribing of biosimilars is certainly growing as companies seek to prove that biosimilars are as safe and effective. In October, the publication of the Nor-Switch study, which looked at the switching of 480 patients in Norway from the biologic Remicade© to the biosimilar Remsima©. The results of the study found that Remsima© was not inferior to Remicade©. The data from this well designed study is helpful – but policy makers must not misinterpret or exaggerate the findings of the NOR-SWITCH trial. Our view is that decisions about switching should always remain with the patient and treating physician.

Where do we go from here?

GAfPA hopes that this week’s gathering in the EU parliament will be the first of many events that helps elevate the physician and patients’ voice in the biosimilars debate. There is more discussion to be had around the implications of switching between biologics and biosimilars, but if this is to be done effectively and appropriately, physicians – and importantly, patients – must be given a seat at the table.