Sponsored – Biosimilars: Production to patient | Page 34

Biosimilars have transformed the treatment landscape in various therapeutic areas , and especially in oncology and supportive care , where they have saved countless lives
Studies investigating the feasibility of oncology supportive care at home are currently ongoing to evaluate common side effects , such as chemotherapyinduced nausea , vomiting , diarrhea , fatigue , and anemia . 19 The primary goal of such investigations is to avoid emergency room and hospital visits by these patients .
Administration Oncology SC biosimilars are not currently licensed for self-administration by patients in the US , even though this already occurs in the UK , 20 and remains to be seen if this will occur in the US market .
Localized site reactions A common problem with SC administration , especially in the early stages , is the likelihood of experiencing localized injection site reactions such as swelling , erythema , pruritus , and pain . 21 While these reactions would normally occur immediately , in some cases it can be delayed by up to 48 hours . 22 The discomfort of localized reactions can be minimized through the application of a cold compress after injecting and use of both anti-histamines and analgesics to lessen the discomfort . In practice , patients should be informed that localized reactions tend to subside after one to two days but to seek medical advice if these reactions do not resolve or worsen . All patients should also be advised to seek urgent medical attention if they develop urticaria , angioedema , or difficulty in breathing .
Furthermore , a significant potential problem with oncology biosimilars is the risk of infection . For example , studies suggest that trastuzumab is associated with a combined risk of both high-grade fever and febrile neutropenia of 8.5 %. 23 A high-grade fever includes symptoms of sweating , chills , and shivering , head and muscle aches , loss of appetite , dehydration , and general weakness . Patients who develop these symptoms should , therefore , seek urgent medical advice . Similarly , anyone with symptoms of high temperature (> 38 0 ) even if they are well , together with shivers , chills , or if they begin to feel unwell because of dizziness , shortness of breath , may have developed febrile neutropenia and should also seek urgent medical advice .
Reporting adverse drug reactions Although clinical trials are designed to collect data on the efficacy of a product , they are also required to provide data on the range and frequency of adverse reactions . Due to their relatively recent introduction , biosimilars are subject to additional monitoring to allow healthcare professionals to report any suspected and currently unknown , adverse drug reactions . Patients are also able to report any suspected adverse drug effects to the FDA using the MedWatch form . 24 The form can be used to report anything from unexpected side-effects , any problems with the quality of the product as well any mislabelling on the package or any of the material supplied with the product .
Conclusions Biosimilars have transformed the treatment landscape in various therapeutic areas and especially in oncology and supportive care , where they have saved countless lives . Greater emphasis on patient education involving biosimilars requires an understanding of the manufacture and clinical equivalence of these agents compared with the original biologics . With a global shift among biosimilar manufacturers towards self-administration to reduce the burden on hospitals and enhance patient convenience , healthcare providers need to become responsive to this change and explore models of care that balance the need for reimbursement and the development of more patient-centered services .
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