HPE Biosimilars: Where are we and what is next? - Page 24


The importance of educating patients and prescribers

Information oriented and planned towards the different stakeholders is a key element that will become crucial to guarantee successful implementation of biosimilars in clinical practice
Maria José Tamés Ana Cristina Riestra Olatz Olariaga Gerardo Cajaraville Pharmacy Department , Onkologikoa Foundation , San Sebastian , Spain
Biologic therapies have revolutionised the treatment of many conditions ; however , these treatments have also influenced global health economies . In fact , the main restriction to their widespread use is their high cost . With the expiration of many patents for these products , authorisation of similar biologic medicinal products , known as biosimilars , has occurred . 1
A biosimilar is a biological product that is approved on the basis of the totality of evidence demonstrating that it is highly similar to an approved biological product ( originator ) in terms of structure , function , quality , clinical efficacy and safety . 2 Biosimilars are officially approved versions of original ‘ innovator ’ products and can be manufactured when the original product ’ s patent expires . 3 Reference to the innovator product is an integral component of the approval .
Unlike common small-molecule generic drugs , biologics generally exhibit high molecular complexity and can be quite sensitive to changes in manufacturing processes . Despite this heterogeneity , all biopharmaceuticals , including biosimilars , must maintain consistent quality characteristics , pharmacology , efficacy , safety , immunogenicity and clinical performance throughout their life cycle . 4 Regulatory agencies have established very strict pathways for the approval of these new agents , thereby providing confidence in their use for health professionals and patients .
A significant impact Biologic medicines play a significant role in patient care across a growing number of disease areas . They are mainly used in inmune-mediated inflammatory diseases such as rheumatoid arthritis , ankylosing spondylitis , psoriatic arthritis , psoriasis , Crohn ’ s disease and ulcerative colitis , and also very strongly in the oncology setting , where they have changed the treatment paradigm for many types of cancer . It is in this area that patent expirations for a number of biologics are imminent , thereby potentially increasing the use of biosimilars in different health systems worldwide .
From an economic perspective , the impact of losses of exclusivity in developed markets is expected to amount to approximately $ 121 billion between 2019 and 2023 , with 80 % of this impact , or $ 95 billion , in the US . By 2023 , biosimilar competition in the biologics market will be nearly three-times greater than it is today . This will result in approximately $ 160 billion saved over the next five years . The cumulative potential savings to health systems in the five major European Union ( EU ) markets and the US , as a result of the use of biosimilars , could exceed 50 billion Euros in total over the next five years and potentially reach as much as 100 billion Euros . 5
The importance of education The ‘ biosimilar concept ’ is quite new , so the need for more information and the need for answers to some doubts that might arise during the decision-making process and in communication among health professionals and their patients is vital .
First , comprehensive information on the results of clinical trials conducted to support the marketing authorisation of biosimilars should be readily available , particularly with respect to the sensitive patient population studied and the sensitivity of the endpoints used . Second , data relating to extrapolation , interchangeability ( switching and substitution ) and immunogenicity should be addressed with clarity , to reassure both clinicians and patients . Finally , awareness of the pharmacovigilance plan ( risk management plan ) is a key point , which is difficult to implement at both hospital and community levels .
From a practical perspective , the introduction of biosimilars into clinical practice usually faces some barriers from different stakeholders involved in the process , especially from prescribers and patients . It is essential that both groups have an accurate and informed understanding of both the challenges and the opportunities that biosimilar treatments offer . They should be fully aware that both the EU and US regulatory processes for the assessment of biosimilar medicines are rigorous and lead to the approval of safe and effective drugs .
According to Lyman , there are five myths about biosimilars that every oncologist should know about and overcome : 6 1 : Cheaper = potentially less safe 2 : Confirmatory trials are too small to detect clinically meaningful differences 3 : Common J-codes will lead to an inability to track safety 4 : Extrapolation is dangerous without clinical trials for each indication 5 : Pharmacovigilance will be poor without different non-proprietary names .
Building confidence through education For prescribers In order to facilitate the process of bringing them into practice , European professional associations , including ESMO and EAHP , have taken a position on the use of biosimilars . They support their use in oncology as they represent cheaper alternatives to reference biologics with the potential to make
24 | 2019 | hospitalpharmacyeurope . com