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The role of the pharmacist as the biosimilar expert

Pharmacists can take the lead in several different ways including formulary development , advice on cost containment , and provision of appropriate education to both physicians and patients , all of which can help facilitate greater biosimilar uptake within an organization
Ali McBride PharmD MS BCOP FASHP FAzPA The University of Arizona Cancer Center and The University of Arizona College of Pharmacy , AZ , USA
Biopharmaceutical drugs or biologics have been widely used in the treatment of a number of conditions including rheumatoid arthritis , psoriasis , ulcerative colitis and various cancers . Although very effective , owing to both high developmental and manufacturing costs , the biologics are extremely expensive and this has led to a marked increased health care expenditure in countries using these drugs . Biosimilars , which are clinically identical to a specific biologic ( the reference product ) were introduced into the European market in 2006 and nine years later in the US . However , although uptake of biosimilars was originally slow in Europe , it has now gathered pace and with over 50 biosimilars approved , the drugs are widely used in many EU countries .
As biosimilars are priced as much as 20 – 30 % lower than the reference product , there is an opportunity for health care providers to offer high quality care at an affordable price . Furthermore , the fiscal room that accrues from a reduction in treatment costs enables providers to treat a larger number of patients . In contrast to Europe , biosimilar uptake in the US has lagged , and while there are a number of reasons that have affected uptake , caution among the clinicians using these drugs , especially around switching from a reference product and concerns over interchangeability , have become noticeable barriers .
As the medication experts , pharmacists have the potential to become biosimilar trailblazers and take a leadership role as part of the multidisciplinary effort to evaluate and support the introduction of these cost-saving , clinically equivalent alternatives . Pharmacists can take the lead in several different ways including formulary development , advice on cost containment as well as the provision of appropriate education to both physicians and patients , all of which can help facilitate greater biosimilar uptake within an organization .
Formulary development Due to their clinical and financial acumen , pharmacists rather than other healthcare professionals are able to adopt a more holistic approach to biosimilars and thus help drive adoption onto a hospital formulary . In addition to the responsibility for the development of a formulary , medication management-related protocols are undertaken by the organization ’ s Pharmacy and Therapeutics committee ( P & T ). Traditionally , the role of pharmacist members has been the development of robust protocols for the implementation of more cost-effective medicines . The introduction of biosimilars has highlighted the importance of this role , given that these agents , while accounting for a relatively small amount of prescribing , have had a disproportionate impact on the organization ’ s overall drug budget . Utilizing their clinical skills , pharmacists are able to undertake an evaluation of the formulary dossiers , to assess a biosimilar in terms of its safety and potential for immunogenicity . 1 Pharmacists can thus reassure fellow P & T members on the available evidence , which indicates that the majority of biosimilars that have received a market authorization are equivalent to their particular reference product . 2 As a wider range of biosimilars is approved by the FDA and enter the market , competition further drives down costs . Using their financial expertise , pharmacists can perform an economic appraisal to inform the P & T on the most cost-effective biosimilar / biosimilars to adopt on the formulary .
Pharmacists can also take clinical responsibility for the development of a biosimilar adoption program to define the range of clinical circumstances ( that is , acute versus chronic ) for which the chosen biosimilars are appropriate . For instance , where the organization is considering a wholesale switch program , in which all patients initially prescribed the reference biologic are changed over to the biosimilar , pharmacists can help develop protocols to facilitate this switch . One of the stumbling blocks to switching is this process should normally only take place when a biosimilar has received an interchangeable designation from the FDA and , to date , none of the approved biosimilars fall into this category . In practice , pharmacists can overcome this hurdle through the development of a specific protocol using the therapeutic interchange process , 3 which will permit substitution of the reference product , provided that the protocol clearly defines the circumstances under which this exchange can take place . Furthermore , pharmacists have an important role in the development of risk management strategies to address any safety concerns over biosimilars and continue to employ therapeutic drug monitoring to optimize dosing when treating patients . Pharmacists can also ensure that formularies consider the formulations available for a biosimilar and in particular , if this is different to the reference product as this may impact how the drug can be used in practice , especially if dosing flexibility is required . For example , the reference biologic Neupogen ( filgrastim ) is available as both an injection vial and a pre-filled syringe . 4 In contrast , the biosimilar , Zarxio ( filgrastim-sndz ) is only available as a pre-filled syringe 5 and thus not amenable to flexible dosing .
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