Biosimilars—why terminology matters

Weise, Martina; Bielsky, Marie-Christine; Smet, Karen De; Ehmann, Falk; Ekman, Niklas; Narayanan, Gopalan; Heim, Hans-Karl; Heinonen, Esa; Ho, Kowid; Thorpe, Robin; Vleminckx, Camille; Wadhwa, Meenu; Schneider, Christian K.

doi:10.1038/nbt.1936

Cited by 185 publications

(154 citation statements)

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“…In order to avoid future problems with terminology for biosimilars and non-biosimilars, it is emphatically proposed that the recommendations expressed in the Weise et al publication [9], are followed. The defi nitions provided in the publication for the terms 'biosimilar' and 'non-innovator biologic' should be adopted in future for accurately referring to the nature of relevant products.…”

Section: Generics and Biosimilars Initiative Journalmentioning

confidence: 99%

“…An even greater problem is that all of these terms have in some cases been used to refer to products which are not biosimilars according to the EU/WHO defi nitions and have not been evaluated using the comparability approach which is essential if the guidelines are followed. This problem of terminology and its implications has been the subject of a recent publication by Weise et al [9], and this paper also recommends the use of more precise terminology for biosimilars (and non-biosimilars) to attempt to clarify the confusing situation.…”

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confidence: 92%

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Terminology for biosimilars–a confusing minefield

Thorpe¹

2012

GaBI J

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Biosimilars are fi rmly established in the EU as copy biologicals with a clear and eff ective regulatory route for approval. Unfortunately, inconsistency in nomenclature for biosimilars has caused confusion. This problem of terminology has been the subject of a recent publication. The confusion is not just a potential concern for patient safety and effi cacy, but also can lead to misconceptions in published reports. Several examples of this have occurred, some of which are discussed below. The defi nitions provided should be adopted for clarity in the future.

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Section: Generics and Biosimilars Initiative Journalmentioning

confidence: 99%

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confidence: 92%

Terminology for biosimilars–a confusing minefield

Thorpe¹

2012

GaBI J

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“…In clinical practice, different preparations of filgrastim are used, including biosimilar drugs (also termed 'biosimilars' or 'follow-on biologicals'). As the name suggests, these products are biologically similar to their original drug counterparts, with similar physicochemical properties, and therefore, should possess similar efficacy and safety (7)(8)(9) The aim of the present study was to determine the characteristics of use of the biosimilar (follow-on) drug filgrastim in the primary and secondary prevention of FN, as well as to evaluate its efficacy and safety.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of biosimilar filgrastim in primary and secondary prevention of febrile neutropenia

et al. 2017

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Abstract. Neutropenia and febrile neutropenia (FN) are among the most common side effects/complications of chemotherapy. The aim of the present study was to evaluate the practice of the use of biosimilar filgrastim in the primary and secondary prevention of FN, and assess its efficacy and safety. A multi-center, non-interventional epidemiological study of 170 cancer patients aged 23-82 years was conducted. Data were collected via a questionnaire completed based on medical documentation and patient examination over five chemotherapy visits. The risk of FN related to the chemotherapy protocol used was in the range of 10-20% in >50% of the patients (53.5%) and a majority (74.7%) had additional FN risk factors. 60% of the patients received filgrastim as primary prevention of FN, and 40% received it as secondary prevention. In 40.6% of cases, six cycles of chemotherapy were used. More than 90% of patients continued chemotherapy according to the initial recommended dose. In majority of patients, no FN was observed following the final cycle of chemotherapy. Median neutrophil count at visit 1 was 2.2x10 3 /µl and did not fall below that level. Majority of patients (>70%) performed self-injections of filgrastim, and 86.3% of patients were continuing therapy with this drug at the last visit. No treatment-related side effects were recorded. The use of biosimilar filgrastim in the primary and secondary prevention of FN allows to maintain initial chemotherapy dosage. Furthermore, the use of biosimilar filgrastim is safe and tolerable, and has a high acceptance by patients. IntroductionMany cytotoxic drugs currently used in cancer treatment are also myelosuppressive due to their toxicity against rapidly dividing cells of the hematopoietic system. Thus, some of the most common side effects/complications of chemotherapy include injury to the hematopoietic system, mainly neutropenia or agranulocytosis. The occurrence of neutropenia, especially clinically significant neutropenia [absolute neutrophil count (ANC) <1x10 3 /µl], is highly unfavorable and dangerous for the patient. Clinically significant neutropenia usually requires delay in the administration of the next cycle of systemic treatment and thereby reduces the dose density. This may have a negative impact on its effectiveness and worsen patient prognosis. Moreover, severe or prolonged neutropenia (ANC <0.5x10 3 /µl, >7 days) is associated with high risk of infectious complications, which require hospitalization and aggressive treatment and may cause high mortality (1,2). Clinically significant neutropenia may also be accompanied by fever in the form of febrile neutropenia (FN). According to the European Society of Medical Oncology (ESMO), FN is defined as a decrease in ANC of <0.5x10 3 /µl or <1x10 3 /µl, with an expected decrease in ANC to <0.5x10 3 /µl within 48 h, accompanied by fever (>38.5˚C) and/or clinical manifestations of sepsis (3-5). Therefore, preventing the incidence of neutropenia and FN during cytotoxic therapy within primary or secondary prevention is high...

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“…These include negative perception and impaired acceptance of biosimilars among prescribing physicians and patients [5,6]. Biosimilar products may be defi ned as For personal use only.…”

Section: Introductionmentioning

confidence: 99%

“…On the other hand, biologicals or biocopies are biological medicinal products that are developed on their own and not directly compared and analyzed against a licensed new biological. It is unknown whether, and which, physicochemical differences exist compared with other biological of the same class [5].…”

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confidence: 99%

Biosimilarity in Latin America

Chiann¹

2013

GaBI J

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Biosimilars—why terminology matters

Cited by 185 publications

References 9 publications

Terminology for biosimilars–a confusing minefield

Terminology for biosimilars–a confusing minefield

Efficacy and safety of biosimilar filgrastim in primary and secondary prevention of febrile neutropenia

Biosimilarity in Latin America

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