Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents—molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs—provide opportunities both to improve healthcare access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns.
Patients with hematologic malignancies and hematopoietic stem cell transplant (HSCT) recipients are at high risk for bacterial bloodstream infections (BSI) owing to resistant organisms. Data describing the outcomes of vancomycin-resistant enterococcal (VRE) BSI in this patient population are limited. We performed a retrospective cohort study of all cases of VRE BSI that occured between February 1996 and December 2002 on the Leukemia/HSCT unit at Barnes-Jewish Hospital. There were 68 episodes of VRE BSI in 60 patients with acute (53%) or chronic (8%) leukemia, non-Hodgkin's lymphoma (22%) or other malignant hematologic disorders (17%). A total of 13, 32 and 32% were recipients of autologous, related and matched-unrelated transplants, respectively. Forty-two of allograft recipients had active acute graft-versus-host disease (GVHD) and 32% chronic GVHD. Only 57% were neutropenic, 52% had refractory/relapsed malignancy and 60% had end organ dysfunction with a median APACHE II score of 17. Median survival after VRE BSI was 19 days. Pneumonia, receipt of anti-fungal drugs and low APACHE II score at the time of the VRE BSI remained significant risk factors for death on multivariable analysis. Our analysis suggests that in patients with hematological malignancies or HSCT, VRE may not have the behavior of a virulent pathogen. VRE BSI may simply be a marker of these patients' already existing critical medical condition.
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