BMI View : While there is a high volume of generic medicine penetration in the UK, comparatively, the uptake of biosimilars has been poor. Savings from small molecule generics are expected to peak in 2015, whereas demand for biologics is only set to continue its upward trend. Therefore, healthcare costs are expected to resume an upward trend unless the government promotes the consumption of biosimilars in order to moderate biologics spending growth. While it is apparent that the government has work to do, we note that industry's role in the promotion of biosimilars is as important.
While the price differential offered by biosimilars is not as large as the price differential offered by generic medicines (some 20-30% compared to 70-90%), this reduction comes off a comparatively high base. Therefore, the increased uptake of biosimilars in the UK has the potential to provide the NHS with considerable cost savings at a time when the country's ageing population is boosting the demand for high-value medicines for the treatment of long-term diseases such as diabetes, cancer and multiple sclerosis.
The biosimilars market in the UK is being driven by epoetin (recombinant human erythropoietin), filgrastim (granulocyte colony stimulating factor) and somatropin (human growth hormone) - however, there has been varying degrees of uptake of the three medicines. Exhibiting strong sales, eighty-three percent of filgrastim volumes utilised in the UK are biosimilars and within specific hospital trusts, clinical guidelines have been rewritten to indicate the biosimilar as a first-line therapy over the originator. The availability of biosimilar filgrastim has boosted the overall filgrastim market, with a 44% increase in overall volume usage of the drug since biosimilars were launched.
|Biosimilar Filgrastim > Originator Filgrastim|
|UK: Daily Consumption Of Filgrastim In Volume Terms (Standard Units)|
While this demonstrates the potential for revenue earning opportunities for biosimilar manufacturers, according to the British Generic Manufacturers Association (BGMA), the overall up-take of biosimilars in the UK has been low compared with other European Union (EU) countries such as Germany and Austria. This is despite the high volume of generic drug penetration within the UK market, which suggests a more challenging environment for biosimilar manufacturers. In 2013, expenditure on generic medicines in the UK was valued at GBP5.78bn (USD8.96bn), accounting for just under 25% of pharmaceutical spending.
|Comparatively Low Use Of Biosimilar Medicines In The UK|
|The Western European Biosimilars Market, Country Rank By Volume, Daily Defined Dose|
Industry View On Biosimilars
Shining a spotlight on biosimilars in the UK, the Association of the British Pharmaceutical Industry (ABPI), which represents innovative research-based biopharmaceutical companies, launched the third edition of its position paper on biosimilar medicines in May 2014. The paper makes seven recommendations covering areas where action is needed by regulators, health technology assessment (HTA) agencies, NHS commissioners and NHS healthcare professionals who prescribe or dispense biosimilar medicines.
Recommendation 1: All biological/biosimilar medicines should be prescribed by brand name and not by International Non-proprietary Name (INN).
Recommendation 2: Automatic substitution is not appropriate for biological medicines including biosimilars. A biological medicine including a biosimilar, must only be substituted under the direct supervision and with the consent of the treating physician.
Recommendation 3: Patients should be kept fully informed about their medication and should be consulted if any changes to their treatment are made.
Recommendation 4: The summary of product characteristics for a biosimilar medicine should clearly indicate the source of information contained within it, such as relevant data from its clinical development programme and clinical data derived from the originator or reference biological medicine.
Recommendation 5: Biosimilar medicines should be subject to health technology assessment processes in the UK.
Recommendation 6: Tenders which are undertaken involving biological medicines should not seek to source a single product only.
Recommendation 7: Extrapolation of indications for biosimilar products should be evaluated by regulators on a case by case basis.
Government Involvement Fundamental
While the paper shows the industry's work on the promotion of biosimilars in the UK, it is vital that the government works to increase the awareness of biosimilars in the country, including the provision of appropriate information and guidance regarding their safety, quality and efficacy. This information should be made available to clinicians not only by the industry but also by HTA bodies (such as the National Institute of Clinical Excellence) based on professional regulatory assessments and other available peer reviewed information. It is vital that clinicians are able to consider switching patients to a more cost-effective biosimilar medicine when one becomes available in the light of available clinical and scientific evidence of the advantages and disadvantages of doing. Furthermore, it is in the interests of the NHS and patients as a whole for clinicians to use more cost-effective equivalent biosimilar medicines when available when starting a patient on a biopharmaceutical.