HPE Biosimilars: Where are we and what is next? | Page 18

than physicians and are ideally placed to promote the use of biosimilars .

Pharmacists have a key role to play in ensuring that patients are fully informed before any potential switch ; preferably via a face-to-face discussion . During this consultation , the patients ’ informed consent to the switch should be documented and the discussion followed-up with a ‘ switch ’ letter shortly before the planned switch date .

Pharmacovigilance is critical to assure the safety of biosimilars and may even be mandatory for some products ; pharmacists play a key role in ensuring the maintenance of accurate and complete records for pharmacovigilance purposes . ¹³

In addition to recording adverse events , baseline disease activity metrics and ongoing review disease metrics post-switch should be documented to enable the early identification of any switch-related concerns .

With the increasing adoption of biosimilars , there are specific operational challenges including differentiating between biosimilars in recording systems . Pharmacists are ideally placed to ensure that electronic prescribing systems enforce the prescribing of biologics and biosimilars by brand name . The administration protocols for these medicines require review with the different brands represented . The brand administered or delivered to the patient should be documented in the patient records and databases , and registries updated to reflect the current brand prescribed .

A comprehensive survey of the knowledge , experience , and opinions of pharmacists , either community-based or working in hospitals , was conducted in France to identify obstacles and potential measures to promote the prescription of biosimilars . The results showed widespread poor knowledge about these products in the community setting and questions about their use such as manufacturing , safety , and substitution , with the main concern relating to patients ’ preference for the originator and indication extrapolation . ¹⁴ However , pharmacists recognise the benefits associated with health care costs savings , and those who had previously dispensed biosimilars felt comfortable educating patients about the advantages of substitution . This study highlights the need for accurate information and training for pharmacists in some European countries to enable an effortless and safe switching process . ¹⁴

Switching to biosimilars in the real world The main factor in the adoption of biosimilars for payers is their price relative to those of the reference medicines . However , the median discounted prices for biosimilars are not as substantial as for generic drugs , ¹⁵ although procurement prices are negotiated in tenders in many European countries for use in the hospital setting and , in some cases , for ambulatory use . ⁴ In addition , some manufacturers of the originator molecules may offer price cuts once their patents expire , further contributing to the competitiveness of the market and making any potential savings associated with biosimilars seem less appealing . In reality , there seems to be a poor correlation between biosimilar adoption and price reduction . ⁶

For physicians , the main concerns are efficacy , safety / tolerability ( both for the approved and extrapolated indications ), lack of long-term data , and interchangeability / pharmacy-driven substitution . Immunogenicity on switching remains a concern but evidence to date is reassuring . Most physicians perceive biosimilars as second- or third-line therapy , indicating specific needs in medical education , which should cover clinical and regulatory aspects as well as specific billing and record documentation processes . ¹⁶

For patients , gaps in knowledge about biosimilars include efficacy , safety and access . Maybe not surprisingly , one of the major factors that influenced the willingness to try treatment with a biosimilar is the manufacturer itself , and there is a common misconception that the lower cost of the biosimilar products implies lower quality ( that is , efficacy / safety ). ¹⁷ Therefore , there is room for pharmacists to fill in these educational gaps and discuss the advantages of biosimilars with patients , which may be complemented with medical education .

Conclusions Even though biosimilars entered the European market more than a decade ago , not all countries have clear guidance on best practices for their inclusion into clinical practice , particularly when patients switch from one biosimilar to another . The adoption of biosimilars promises attractive price advantages and improved patient access but presents challenges from the operational and clinical point of view , with transitions of care and medication reconciliation requiring special attention .

Although the decision to prescribe a biosimilar ultimately rests on the responsible physician upon discussions with the patient , pharmacists play a key role in the development of strategies to switch patients to biosimilars in a safe manner , by providing accurate information , promoting their acceptance , and ensuring proper use . As payer strategies evolve and the economic incentives toward the use of biosimilar medicines increase , as occurred in the past for generic drugs , the pressure on pricing for reference biologics will eventually increase , with potential reductions in overall cost of care .

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