Position of Scientific Oncological Societies Towards Biosimilar Antibodies

Abstract

First biosimilars of monoclonal antibodies have recently been approved in oncology. Biosimilars enable economic competition, alleviate the financial burden for insurances, and may facilitate access to these drugs in low-income countries. Biosimilars are not completely identical to the original drug. The approval of biosimilars is only partially based on results of randomized clinical studies. In the introduction phase of new biosimilars, this can lead to uncertainties for patients and physicians. Based on the current clinical data and experiences, biosimilars of monoclonal antibodies in oncology show no significant differences in pharmacokinetics, efficacy, and safety in comparison to the patented originals. Scientific medical societies recommend the use of biosimilar monoclonal antibodies and support switching in long-term treatments. However, the use of biosimilars for off-label indications requires additional attention towards efficacy and safety. Active counselling of the patient by the treating physician is the most important step in the informed consent process, especially when switching from an original to a biosimilar. Careful documentation of the prescribed drug and enhanced pharmacovigilance are recommended for the use of biosimilars.

Trastuzumab Biosimilars in the Therapy of Breast Cancer – “Real World” Experiences from four Bavarian University Breast Centres

“…This showed that subsequently almost 80% of the oncology patients were able to answer correctly questions regarding marketing authorisation, reporting of side effects and cost management of biosimilars 27 . The German Society for Haematology and Oncology (DGHO) recommends dedicated briefing by the treating physician 28 . The European Society for Medical Oncology (ESMO) emphasizes the necessity of educating the prescribing physicians, nursing staff and patients in the use of biosimilars 14 .…”

“…Since biosimilars are similar to the reference drug but – like different batches of the reference drug – are not identical, new side effects may arise. For example, increased immunogenicity caused by altered glycosylation or an increase in neutralising antibodies may occur 28 . In our surveyed centres, side effects with the biosimilar therapy essentially corresponded to the adverse drug reactions described in the Summary of Product Characteristics.…”

“…The American and European Medicines Control Agencies as well as the Medicines Commission of the German Medical Association issued statements on the safety and efficacy and on the implementation of biosimilars in the clinical practice 30 , 31 , 32 . An independent registry to record side effects might be helpful 28 . The modern ordering systems of the clinics ensure traceability of substance switching.…”

“…Hier zeigte sich, dass im Anschluss fast 80 % der onkologischen Patienten Fragen bezüglich Zulassung, Nebenwirkungsmeldung und Kostenmanagement im Zusammenhang mit Biosimilars korrekt beantworten konnten [27]. Die Deutsche Gesellschaft für Hämatologie und Onkologie (DGHO) empfiehlt eine dezidierte Aufklärung durch den behandelnden Arzt [28]. Die europäische Gesellschaft für medizinische Onkologie (ESMO) betont die Notwendigkeit der Schulung von verschreibenden Ärzten, Pflegepersonal und Patienten beim Einsatz von Biosimilars [14].…”

“…Da Biosimilars dem Referenzarzneimittel ähnlich, aber – analog verschiedener Chargen des Referenzarzneimittels – nicht identisch sind, können neue Nebenwirkungen auftreten. Beispielsweise können eine erhöhte Immunogenität durch eine veränderte Glykosylierung oder vermehrt neutralisierende Antikörper vorliegen 28 . In unseren erfassten Zentren entsprachen Nebenwirkungen unter Biosimilartherapie im Wesentlichen den in der Fachinformation genannten unerwünschten Arzneimittelwirkungen.…”