Real-world safety experience of tevagrastim/ratiograstim/biograstim and tbo-filgrastim, short-acting recombinant human granulocyte colony-stimulating factors

• Published in: Supportive care in cancer Vol. 27; no. 7; pp. 2569 - 2577
• Main Authors: Abboud, Camille N., Lang, Nicole, Fung, Henry, Lammerich, Andreas, Buchner, Anton, Liu, Patrick, Mueller, Udo, Pettengell, Ruth, Diel, Ingo J., Link, Hartmut, Pathak, Ashutosh
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-07-2019; Springer; Springer Nature B.V
• Subjects: Biological products; Biosimilar Pharmaceuticals - administration & dosage; Biosimilar Pharmaceuticals - adverse effects; Blood cell count; Cancer; Chemotherapy; Complications and side effects; Europe; Filgrastim - administration & dosage; Filgrastim - adverse effects; Granulocyte colony-stimulating factor; Granulocyte Colony-Stimulating Factor - administration & dosage; Granulocyte Colony-Stimulating Factor - adverse effects; Granulocytes; Humans; Medicine; Medicine & Public Health; Nursing; Nursing Research; Oncology; Original Article; Pain Medicine; Patient safety; Product Surveillance, Postmarketing; Puerto Rico; Recombinant Proteins - administration & dosage; Recombinant Proteins - adverse effects; Rehabilitation Medicine; Safety and security measures; Safety regulations; Side effects; Puerto Rico; Europe; United States > US; Pharmacovigilance; Postmarket surveillance; Tbo-filgrastim; G-CSF; Filgrastim; Febrile neutropenia
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-018-4522-5

Purpose
Recombinant granulocyte colony-stimulating factors (rG-CSFs), such as filgrastim, are administered to prevent complications in patients receiving chemotherapy. In Europe, a biosimilar to filgrastim, tevagrastim/ratiograstim/biograstim, was approved in 2008. In the USA, the same product was approved as tbo-filgrastim under a 351(a) biologic license application in 2012 with the brand name Granix®. Postmarket surveillance remains a priority for monitoring the safety of biologics and biosimilars to identify rare and immunogenicity-related events. We report the global and US pharmacovigilance data for tevagrastim/ratiograstim/biograstim and tbo-filgrastim, respectively.
Methods
Cumulative exposure and adverse event data from initial approval in Europe to December 31, 2016, were collected globally from spontaneous reports submitted by healthcare professionals and consumers, scientific literature, competent authorities, and solicited case reports from non-interventional studies. A separate search was conducted on the global data set to identify reports originating from the USA and Puerto Rico to describe the US experience.
Results
Overall, the global safety profile of tevagrastim/ratiograstim/biograstim in the postmarket, real-world setting was comparable to clinical trial experience. Postmarket safety experience of tbo-filgrastim in the USA was consistent with global data. The most common SAEs were febrile neutropenia and decreased white blood cell count. The most common non-serious event was bone pain. There was no evidence of immunogenicity.
Conclusions
This pharmacovigilance analysis indicates that postmarket experience of tevagrastim/ratiograstim/biograstim and tbo-filgrastim is consistent with clinical trials. Adverse reactions associated with the originator rG-CSF (capillary leak syndrome and glomerulonephritis) have not been observed with tevagrastim/ratiograstim/biograstim or tbo-filgrastim during the postmarket period.