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Adopting biosimilars in clinical practice : the pharmacist ’ s role
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
Caron Underhill Dip Clin Pharm IPresc Specialist Biologics Pharmacist , University Hospital Southampton NHS Foundation Trust , UK
The European Medicines Agency ( EMA ) defines a biosimilar as a therapeutic agent that is structurally similar to a biological medicinal product that has already been approved for a specific indication – the reference product or originator . In addition to structure , a biosimilar is required to show similarity in physicochemical characteristics and efficacy , as well as safety . This ‘ bioequivalence ’ is determined based on comprehensive analyses conducted to demonstrate that the candidate biosimilar medicine is not significantly distinct from the reference product and is therefore unlikely to present any clinically significant differences . 1
Biologics are more complex than traditional small-molecule drugs , which are usually produced by chemical reactions and have a stable and consistent structure that is independent of the manufacturing process . By contrast , biologics are produced in living systems and have inherent microheterogeneity with high molecular weights and are sensitive to manufacturing conditions . These can be difficult to fully characterise and / or replicate . The regulatory approval process for biosimilars does not involve a full therapeutic equivalence study , but proof of pharmacological bioequivalence and demonstration of efficacy in one of the ‘ sensitive ’ indications approved for the originator . 1 Clinicians are familiar with the use of clinical trial data to determine efficacy of medicines but the acceptance of biosimilar medicines for extrapolated indications requires a belief that analytical demonstration of similarity will demonstrate clinical efficacy . 2 The biosimilars ’ market has gained importance in the past decade in Europe as well as in many parts of the world , owing to the great potential for savings and genuine interest on the part of health systems in controlling ever-increasing health care costs . The first biosimilar product , a recombinant human growth hormone , was approved by the EMA in 2006 , and many other medicines , ranging from haematopoietic growth factors to monoclonal antibodies and insulin , have received market authorisation since then . 1 , 3 Despite the obvious advantage of lower acquisition prices for health systems in general and patients in particular , pricing and reimbursement , prescription policies and incentives at national level influence their uptake in the different countries . 4 – 6
Current status of biosimilar use : UK perspective The status of use of biosimilar medicines in Europe varies from country to country . In the UK , where biosimilars have been commercially available since 2007 , there is also variation from region to region .
The National Health Service ( NHS ) in England has published guidance for commissioning biological medicines and biosimilars , estimating savings of hundreds of millions of pounds per year by 2020 – 2021 . As more and more biosimilars become commercially available , the main objective is to have at least 90 % of new patients taking the medicine presenting the best value within three months of the introduction in the market of a biosimilar medicine , and at least 80 % of existing patients switching to the biosimilar within one year . This collaborative effort involves the prescribers , as well as patients , health care providers , commissioners , and regulatory agencies , and requires good coordination and alignment across the different stakeholders . 7
To enhance productive partnerships between the relevant stakeholders , regional optimisation committees were formed to provide support at the local level and make recommendations on the optimal use of these medicines by sharing best practices , analysing real-world evidence , and coordinating any changes needed , thus reducing variability in the introduction and use of biosimilars into clinical practice . In order to maximise the adoption of biosimilars , financial arrangements can be made such as introducing incentives , at the hospitals ’ department level , to cover for expenses incurred with the resources needed to implement the switch to biosimilars , which can then be reinvested to meet other patient and staff needs . Prices for originators and biosimilars can also be ( re ) negotiated , always taking into consideration the cost of administering a particular medicine ( that is , training of medical personnel and / or patients , patient support initiatives , and price per dose ). 7
Currently , automatic substitution of biologics at the point of dispensing is not allowed in the UK , 7 in contrast to some Eastern European countries as well as Germany and France , where substitution of a reference product with a biosimilar medicine is authorised for patients who initiate treatment , as well as for treatment-experienced patients provided they are informed of the switch and are monitored for efficacy and safety purposes . However , most of the European countries ( still ) do not allow biosimilar substitution at the pharmacy level . 4
Evaluation of biosimilars for inclusion in formularies The assessment of opportunities for the inclusion of biosimilars starts with the identification of the current standard therapies with the originator products and their priorities or areas for exclusions . Guidance from the NHS and homologous entities ,
16 | 2019 | hospitalpharmacyeurope . com