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Expert perspectives on biosimilar monoclonal antibodies in breast cancer.

ABSTRACT: While biosimilars of low molecular-weight biologics such as G-CSF have been available in Europe since 2006, biosimilars of monoclonal antibodies (mAbs) have only become available in the last year. Unlike G-CSF, mAbs are large and complex and often play a direct role in the survival of patients with life-threatening illnesses such as breast cancer. Several biosimilars are currently under development for the treatment of breast cancer, and the use of biosimilars in a setting that directly impacts patient survival raises a number of questions. In this review, we discuss the biosimilar mAbs currently in development for the treatment of breast cancer. We provide an overview of the European Medicine Agency guidelines and historic data on the development of biosimilars in order to discuss the development of biosimilar mAbs for breast cancer. Biosimilars offer a highly attractive path toward reducing the cost of medical care and should be pursued with great interest. However, for agents used to treat life-threatening diseases such as cancer, a cautious approach must be taken to ensure that there is no negative impact on patient care. Clinical trials for biosimilar mAbs must be carried out in an appropriately sensitive patient population using endpoints that can accurately demonstrate both the similarity of the biosimilar and its efficacy in the indication. Due to the abbreviated approval pathway, rigorous pharmacovigilance must be in place once a biosimilar mAb is approved in order to ensure its long-term safety and efficacy.

SUBMITTER: Cortes J

PROVIDER: S-EPMC3949011 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundBiosimilars have been used for 15 years in the European Union (EU), and have been shown to reduce costs and increase access to important biological medicines. In spite of their considerable exposure and excellent safety record, many prescribers still have doubts on the safety and interchangeability of biosimilars, especially monoclonal antibodies (mAbs) and fusion proteins.ObjectivesThe aim of this study was to analyse the short- and long-term safety and interchangeability data of biosimilar mAbs and fusion proteins to provide unbiased information to prescribers and policy makers.MethodsData on the safety, immunogenicity and interchangeability of EU-licensed mAbs and fusion proteins were examined using European Public Assessment Reports (EPARs) and postmarketing safety surveillance reports from the European Medicines Agency (EMA). As recent biosimilar approvals allow self-administration by patients by the subcutaneous route, the administration devices were also analyzed.ResultsPrelicensing data of EPARs (six different biosimilar adalimumabs, three infliximabs, three etanercepts, three rituximabs, two bevacizumabs, and six trastuzumabs) revealed that the frequency of fatal treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation of treatment, serious adverse events (SAEs), and main immune-mediated adverse events (AEs) were comparable between the biosimilars and their reference products. The availability of new biosimilar presentations and administration devices may add to patient choice and be an emerging factor in the decision to switch patients. Analysis of postmarketing surveillance data covering up to 7 years of follow-up did not reveal any biosimilar-specific adverse effects. No product was withdrawn for safety reasons. This is in spite of considerable exposure to biosimilars in treatment-naïve patients and in patients switched from the reference medicinal product to the biosimilar. Analysis of data from switching studies provided in regulatory submissions showed that single or multiple switches between the originator and its biosimilar versions had no negative impact on efficacy, safety or immunogenicity.ConclusionsIn line with previous reports of prelicensing studies of biosimilar mAbs and etanercepts, this study demonstrated comparable efficacy, safety, and immunogenicity compared with the reference products. This is the first study to comprehensively analyze postmarketing surveillance data of the biosimilar mAbs and etanercept. An analysis of more than 1 million patient-treatment years of safety data raised no safety concerns. Based on these data, we argue that biosimilars approved in the EU are highly similar to and interchangeable with their reference products. Thus, additional systematic switch studies are not required to support the switching of patients.

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Expert perspectives on biosimilar monoclonal antibodies in breast cancer.

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