Oncology

An editorial recently published in The BMJ discusses addresses 1 of the most commonly misunderstood biosimilar concepts: extrapolation.
This week, the American Society of Clinical Oncology (ASCO) released a new statement that seeks to offer clinicians guidance on the use of biosimilars in oncology as a wave of patent expirations is expected to bring more anti-cancer and supportive care biosimilars to the US market.
 
A study recently published in the European Journal of Hematology reports diffuse large B-cell lymphoma (DLBCL)–specific findings from MONITOR-GCSF, a pan-European, multicenter, prospective, observational study that attempts to describe the treatment patterns and clinical outcomes of patients who received biosimilar filgrastim in the prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia.  
Hope Rugo, MD, director of the breast oncology clinical trials program at the University of California at San Francisco, disucusses the conversations she is having and expects to have with fellow prescribers about biosimilars in oncology.
Celltrion’s head of strategy and operations, Ho Ung Kim, told reporters this week that the intravenous Herzuma could be launched at as much as a 50% discount to a subcutaneously administered presentation of the reference Herceptin.
Higher levels of cancer-related financial toxicity are associated with decreased quality of life, poorer treatment adherence, and poorer survival for adult patients with cancer.
The early weeks of 2018 held substantial developments for oncology biosimilars in the United States and around the world, with new products on the horizon and evolving challenges in bringing these drugs to the marketplace.
A study newly published in the Journal of Clinical Oncology found that SB3, a proposed trastuzumab biosimilar being developed by Samsung Bioepis, demonstrated equivalence with European-sourced reference trastuzumab (Herceptin) in terms of breast pathologic complete response (bpCR) rate. Safety and immunogenicity for the 2 drugs were also similar.
Amanda Forys, MSPH, and Christy M. Gamble, JD, DrPH, MPH, discuss barriers in patient access to biosimilars.
Zarxio, a biosimilar filgrastim approved in the United States in 2015, was demonstrated to have no clinically meaningful differences from its reference in a randomized clinical trial setting, but data on its effectiveness in preventing febrile neutropenia (FN) a real-world setting have been limited thus far.
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