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Statistical Methods for Assessing Biosimilarity
Published in Laszlo Endrenyi, Paul Jules Declerck, Shein-Chung Chow, Biosimilar Drug Product Development, 2017
Recently, following the Advisory Committee’s recommendation for approval of a proposed biosimilar (by Novartis) to Amgen’s Neupogen (filgrastim) on January 7, 2015, the FDA approved the proposed biosimilar on March 26, 2015. Neupogen was originally approved by the FDA in 1991, and its patent expired in December 2013. Neupogen was intended to decrease the incidence of infection, as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It should be noted that the approved biosimilar of filgrastim is different from Teva’s Neutroval approved by the FDA in August 2012. The approval of Teva’s Neutroval was based on a full biologic license application rather than under the FDA’s new biosimilar approval pathway which allows Teva to compete directly with Amgen’s filgrastim in the United States.
EMA-approved biosimilars
Published in Sarfaraz K. Niazi, Biosimilars and Interchangeable Biologics, 2016
G-CSFs are growth factors, which are used to restore neutrophil production in patients undergoing chemotherapy. Febrile neutropenia is a life-threatening complication for patients undergoing chemotherapy. It causes a loss of neutrophils and fever.
Variability in body temperature in healthy adults and in patients receiving chemotherapy: prospective observational cohort study
Published in Journal of Medical Engineering & Technology, 2019
J. S. Frazer, G. E. Barnes, V. Woodcock, E. Flanagan, T. Littlewood, R. J. Stevens, S. Fleming, H. F. Ashdown
We collected details from each participant and also sought permission to view their medical records to corroborate information. We recorded demographic details including age and sex, and recorded the current cancer diagnosis, chemotherapy regimen, cycle duration, past medical history, and current medications. Patients were provided with a variable number of diaries based on their expected future number of cycles (one diary per cycle). The diaries were similar to those used by the healthy volunteers, with additional space to provide details of any hospital admissions during the recording period, as well as a separate section for recording details of the thermometer(s) used to measure temperature (including brand, model, location of purchase, duration of ownership, and site of temperature measurement). As guidance given to patients on temperature monitoring during chemotherapy treatment varies, we asked them not to change their existing or planned practice but simply to record their temperature in the diary when they were checking it routinely. Participants were explicitly told not to contact the research team in the event of being unwell but to seek medical advice as instructed by their supervising clinicians. Participants returned completed diaries (anonymised using participant-specific codes) to the study team in prepaid envelopes. Patients were contacted up to two times if no diaries were received by the study team. We checked medical records retrospectively for the period of temperature recording and any intervening periods to ensure there had been no admissions for neutropenic sepsis not recorded by the participants themselves. In addition to what was recorded in the diaries, we retrospectively reviewed the electronic medical records for all those who returned diaries. We counted an admission as due to neutropenic sepsis when this was recorded as such in the patient booklet, or when 'neutropenic sepsis', 'febrile neutropenia', or similar were included as part of the diagnosis in the discharge letter or other patient notes.