HPE HPE Fresenius Kabi handbook - Page 26

coverage can also exacerbate financial constraints that result in differences in equality in access to treatment and care. 2,3 In addition, the commercialisation of biosimilars may extend the current indications of their reference products. This can occur when the reference product is approved for an additional indication, which results in registration of this new indication for the biosimilar without conducting further clinical trials. This significantly reduces the investment in time and resources in the development of the biosimilar. However, this process of ‘extrapolation’, which is usually done when changes in the manufacturing process of the reference products are introduced, is not widely accepted when it refers to new indications, and may not be applicable to all types of molecules. 2 Nonetheless, not all patients may agree with a switch from branded drug to biosimilar, for several reasons, and they should be informed that a biosimilar may not be identical to the reference drug and that close monitoring may be needed during the transition process. 1 Moreover, with the increased availability of biosimilars, these agents might be the first choice in some cases, or even when a switch is needed due to formulary changes. There is currently a dearth of data in regard to the potential risks and benefits of multiple switches and of alternating between a reference biologic and its biosimilar. Likewise, comparative studies of different switching strategies with adequate power to evaluate non- inferiority or equivalence between reference and the corresponding biosimilar are lacking. 3 Payers Considering the increase in costs associated with 26 | 2019 | hospitalpharmacyeurope.com References 1 Blumer I, Edelman S. Biosimilar insulins are coming: The top 10 things you should know. Postgrad Med 2014;126(3):107–10. 2 Zalcberg J. Biosimilars are coming: ready or not. Intern Med J 2018;48(9):1027–34. 3 Carrascosa JM et al. Biosimilar drugs for psoriasis: Principles, present, and near future. Dermatol Ther (Heidelb) 2018;8(2):173–94. 4 Uhlig T, Guro LG. Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons. Rheumatology (Oxford) 2017:56(supp 4):iv49–62. 5 Edelman S et al. Biosimilar insulins are coming: what they are, what you need to know. Curr Med Res Opin 2014;30(1): 2217–22. 6 Mestre-Ferrandiz J et al. Biosimilars: How can payers get long-term savings? Pharmacoeconomics 2016;34(6):609–16. drug development in recent years, which have translated into higher prices for payers and direct consumers, insurers have long been considering alternatives to costly drugs, the benefits of which outweigh costs, that do not jeopardise safety and clinical outcomes in the long term. As for generic small-molecule drugs, the introduction of biosimilars can contribute to substantial cost savings, although at a reduced scale given the complexity of the manufacturing process for biologics and their copies. It cannot be ignored that the availability of biosimilars at lower prices might have an impact on the price of their reference products. If they are widely used, biosimilars can potentially lead to lower prices through competition. 2,5 Moreover, biosimilars can create opportunities for research on new agents and/or stimulate innovation with existing molecules (for example, new cell lines used to produce the biosimilar). The increasing availability of biosimilar versions for the same reference is an incentive for companies to promote the advantages of their own biosimilars versus the competitors, and may encourage the generation of efficacy and safety data for new indications not attributed to the reference molecule. 2 Current obstacles to a broader use of biosimilars include insufficient funding and education and variable approaches to healthcare management across countries. Administrative barriers, prescribing restrictions, and absence of well-defined clinical criteria for the initiation, discontinuation, and maintenance of biosimilars may also play a role in limiting access to treatment. To circumvent some of these difficulties, governments can create incentives at the hospital and clinical level to promote use of biosimilars. Support for monitoring and pharmacovigilance programs are also valid strategies that foster a competitive market, resulting in price reductions, while increasing the willingness of both clinicians and budget holders to use lower-cost products whenever feasible. At the pharmacy level, clear regulations for substitution are needed, although automatic substitution is controversial. 3,4,6 In order to determine the impact of biosimilars on healthcare systems, real-world studies are needed to examine the effect on budgets and resource utilisation as well as on pricing practices resulting from the use of biosimilars. High-quality outcomes data will ultimately support the introduction of substitution regulations and the update of prescribing guidelines. 6 Conclusions In summary, prescribers, as well as other health professionals, payers, and patients, should be aware of the potential advantages and disadvantages of biosimilars in order to allow for an optimal treatment plan, one that is adapted to the patients’ particular conditions, needs, and preferences. Biologics used in the treatment of cancer and inflammatory diseases have been available for some time, but few studies have evaluated their effectiveness in the real-world. Moreover, some biologic agents may still have an overall high cost, which limits their widespread and rapid uptake. Therefore, increased awareness of these drugs and how they are developed, as well as of the concept of biosimilarity and the current regulatory framework, by prescribers and allied healthcare professionals can play a significant role in increasing confidence regarding the use of these drugs, not only for clinicians but also for patients.