OPINION: ‘More work remains if biosimilars are to fulfil their potential’
pharmafile | October 27, 2015 | Feature | Manufacturing and Production, Research and Development, Sales and Marketing | British Generic Manufacturers Association, NHS, bgma, biosimilars, generics, patent cliff, patents
Despite having a mature generics market which fulfils more than three-quarters of all prescriptions in the UK, and as a result delivers some of the lowest medicines prices in Europe, there still remains a surprising degree of mystery surrounding the next generation of biological and biosimilar treatments compared with other countries.
However, these are not medicines of the future. They are already having a significant impact from a global perspective and the challenge now for the UK – from both a patient and payer perspective – is how to harness their potential more widely and provide increased access and greater value to the NHS.
Currently, there are four biosimilar medicines available in the UK. However, this is set to increase in the coming years due to a number of factors including patent expiries, and increasing clinical awareness and knowledge, as well as supportive regulatory guidance from organisations such as NICE.
The supportive environment from NICE has been particularly crucial. In November last year, it published its review of erythropoiesis-stimulating agents (epoetin and darbepoetin) for treating anaemia in people with cancer having chemotherapy. The appraisal covered two biosimilar medicines, Sandoz’s Binocrit and Hospira’s Retacrit, each of which is referenced to Eprex (epoetin alfa).
It concluded that erythropoiesis-stimulating agents (ESAs; epoetin alfa, beta, theta and zeta and darbepoetin alfa) are recommended, within their marketing authorisations, as options for treating anaemia in people with cancer who are having chemotherapy.
Furthermore, if different erythropoiesis-stimulating agents are equally suitable, the product with the lowest acquisition cost for the course of treatment should be used.
In February of this year, NICE published its review of infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis. The guidance incorporated biosimilar versions of infliximab and stated that if more than one suitable treatment is available than the least expensive should be used by clinicians.
Most recently, NICE published a final appraisal determination, which recommended biosimilar infliximab as an option for the treatment of severe rheumatoid arthritis, following a multiple technology appraisal. NICE also recommended that treatment should be started with the least expensive medicine, which is likely to be the biosimilar.
The document is the first collaborative publication on biosimilar medicines at a country level. It follows the 2013 launch of the European Commission’s consensus document, “What you need to know about biosimilar medicinal products.”
However, while these announcements are positive, we believe a number of other changes need to happen if biosimilars are to reach their full potential in the UK. A recent study undertaken by GfK Market Access, on behalf of the European Biosimilars Group (EBG), a sector group of the European Generic and Biosimilar Medicines Association, outlined a series of measures that will drive the establishment of a sustainable biosimilar medicines market. GfK’s report highlights that there are four elements which need to be considered holistically to provide a sustainable policy framework for the biosimilar market. These are:
• Education and understanding
• Experience and use
• Rational decision making
• Sustainable pricing.
However, more specifically for the UK to maximise the benefits to patients and the NHS, it is important that the following measures are also promoted appropriately:
– Where the clinical considerations are equivalent, clinicians should routinely prescribe biosimilar medicines for new patients rather than the equivalent, the more expensive originator product – Clinicians should consider switching patients to a more cost-effective biosimilar medicine when one becomes available, but only in the light of available clinical and scientific evidence and appropriate clinical protocols
– Appropriate information and guidance should be made available to clinicians – not only by industry but also by health technology appraisal bodies including NICE, the Scottish Medicines Consortium (SMC) and the All Wales Medicines Strategy Group (AWMSG), and other organisations such as NHS England, based on professional regulatory assessment and other available peer-reviewed information
– There are no unnecessary barriers to the use of biosimilar medicines within the NHS, nor to their development and production in the UK. We believe that the use of biosimilars increases access to important medicines by creating competition and encouraging further innovation in life saving therapies – much like the generic model has done for many years. Competition provides the necessary incentive for originator companies to develop new biological medicines, and biosimilars themselves often demonstrate incremental innovation. This delivers additional clinical benefit or added value, enhancing patient treatment and outcomes.
Moving forward, our role as an industry is to promote the benefits of these medicines to patients’ representatives, healthcare professionals, regulators and payers, to increase understanding and to drive a sustainable environment for the development, production and continuing optimised use of biosimilar medicines across the UK.
In order for them to fully realise their potential from a patient benefit and savings perspective, policy makers need to reflect these developments. This often means that a new, more nuanced thinking is sometimes required. Without it, the UK could face falling behind the rest of Europe in gaining access to these vital medicines.
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