Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch
ConclusionsThis is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as...
Source: Drug Safety - October 30, 2023 Category: Drugs & Pharmacology Source Type: research
Case report: Use of granulocyte-colony stimulating factor as an immunomodulatory therapy in a patient with neuromyelitis optica spectrum disorder and comorbid immunodeficiency
ConclusionG-CSF is a polyfunctional cytokine with important immunomodulatory effects, which makes it an interesting therapeutic option when autoimmunity coexists with immunodeficiency and was used successfully in this case. (Source: Frontiers in Neurology)
Source: Frontiers in Neurology - September 20, 2023 Category: Neurology Source Type: research
Cost-effectiveness of granulocyte colony-stimulating factors (G-CSFs) for the prevention of febrile neutropenia (FN) in patients with cancer
ConclusionsBiosimilar filgrastim and pegfilgrastim as primary prophylaxis are cost-effective approaches to avoid FN events in patients with BC, NSCLC, or NHL at intermediate risk for FN in Austria, France, and Germany. (Source: Supportive Care in Cancer)
Source: Supportive Care in Cancer - September 20, 2023 Category: Cancer & Oncology Source Type: research
Loss of CD34 < sup > + < /sup > Cells and Effect of the Number of Viable Cryopreserved CD34 < sup > + < /sup > Cells in the Infused Blood Grafts on Hematologic Recovery, Progression-Free Survival and Overall Survival in NHL Patients After Autologous Stem Cell Transplantation
CONCLUSIONS: G-CSF type used in mobilization and mobilization capacity were found to correlate with viable CD34+ cell loss during processing and storage. Most importantly, low infused viable CD34+ cell count did not seem to impact on PFS or OS.PMID:37684185 | DOI:10.1016/j.clml.2023.08.009 (Source: Clinical Lymphoma and Myeloma)
Source: Clinical Lymphoma and Myeloma - September 8, 2023 Category: Cancer & Oncology Authors: Anu Partanen Antti Turunen Jaakko Valtola Marja Py örälä Outi Kuittinen Hanne Kuitunen Kaija Vasala Karri Penttil ä Taru Kuittinen Pentti M äntymaa Jukka Pelkonen Esa Jantunen Ville Varmavuo Source Type: research
Prescription patterns of granulocyte colony –stimulating factors in patients with breast cancer: A real-world study
ConclusionsOur study results show that G-CSFs are used for primary prophylaxis in a small percentage of patients with breast cancer and the duration of short-acting G-CSF use is relatively short. Considering the significant clinical and economic impact of FN, it is hoped that the prescription patterns of G-CSFs observed can provide an important reference for future clinical practice and reimbursement policy. (Source: PLoS One)
Source: PLoS One - July 17, 2023 Category: Biomedical Science Authors: Shu-Wei Hsu Source Type: research
Association Between New 340B Program Participation and Commercial Insurance Spending on Outpatient Biologic Oncology Drugs
CONCLUSIONS AND RELEVANCE: In this cohort study, new 340B participation was associated with statistically significant higher oncological drug episode spending compared with nonparticipants after changes in 340B inclusion rules in 2010. These findings raise questions about unintended consequences of the 340B program on drug spending from the commercially insured population.PMID:37351874 | DOI:10.1001/jamahealthforum.2023.1485 (Source: Cancer Control)
Source: Cancer Control - June 23, 2023 Category: Cancer & Oncology Authors: Jessica Chang Pinar Karaca-Mandic Sayeh Nikpay Molly Moore Jeffery Source Type: research
Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation
In conclusion, pegfilgrastim and its biosimilar displayed an advantageous efficacy and safety profile compared with biosimilar filgrastim in patients with MM post-ASCT . (Source: Annals of Hematology)
Source: Annals of Hematology - June 15, 2023 Category: Hematology Source Type: research
HPR115 Patient and Provider Factors Associated with Filgrastim Biosimilar Uptake in the U.S.
Biosimilars become available after the originator ’s period of market exclusivity and offer the possibility of price competition. Biosimilar market uptake has so far been variable. We evaluated patient and provider factors associated with use of biosimilar filgrastim, the first biosimilar marketed in the US. (Source: Value in Health)
Source: Value in Health - June 1, 2023 Category: International Medicine & Public Health Authors: D. Hong, A.S. Kesselheim, A. Sarpatwari, B. Rome Source Type: research
Aortitis Associated with Prophylactic Short-acting Granulocyte Colony-stimulating Factor Administration: A Case Report and Review of the Literature
Intern Med. 2023;62(11):1647-1652. doi: 10.2169/internalmedicine.0599-22. Epub 2023 Jun 1.ABSTRACTWe herein report an 83-year-old woman with filgrastim-associated aortitis during chemotherapy for relapsed diffuse large B-cell lymphoma. She had been treated with filgrastim as a prophylaxis for neutropenia during the fourth cycle of chemotherapy from day 9 to 18. On day 21, she developed a fever. Contrast-enhanced computed tomography revealed aortitis of the descending aorta. The fever abated with non-steroidal anti-inflammatory drug treatment. A literature review identified a small number of aortitis cases all caused by pro...
Source: Internal Medicine - May 31, 2023 Category: Internal Medicine Authors: Yasutaka Masuda Takashi Oyama Kumi Nakazaki Yudai Nakai Ken Sasaki Kensuke Matsuda Yosuke Masamoto Mineo Kurokawa Source Type: research
