Clinical experience with Zarzio® in Europe: what have we learned?
Pere Gascón,Hans Tesch,Karl Verpoort,Maria Sofia Rosati,Nello Salesi,Samir G. Agrawal,Nils Wilking,Helen Barker,Michael Muenzberg,Matthew Turner +9 more
Reads0
Chats0
TLDR
A pooled analysis of five post-approval studies of biosimilar G-CSF (Zarzio®) that included 1,302 adult patients who received at least one cycle of chemotherapy with G- CSF support for the prevention of neutropenia found that initial concerns about the use of biosimilars appear to be unfounded.Abstract:
Biosimilars are similar, but non-identical, versions of existing biological drugs for which patents have expired. Despite the rigorous approval process for biosimilars, concerns have been expressed about the efficacy and safety of these products in clinical practice. Biosimilars of filgrastim, based on the originator product Neupogen®, have been available since 2008 and are now in widespread clinical use in Europe and elsewhere. Three biosimilar G-CSFs have been approved based on a combination of physicochemical and biological protein characterisation, pharmacokinetic and pharmacodynamic assessment in healthy volunteers and efficacy and safety data in patients with cancer. To assess whether biosimilars are effective in the real-world clinical practice setting, a pooled analysis of five post-approval studies of biosimilar G-CSF (Zarzio®) that included 1,302 adult patients who received at least one cycle of chemotherapy with G-CSF support for the prevention of neutropenia was conducted. A total of 36 % of patients had a febrile neutropenia risk of >20 %, while 39.6 % had a risk of 10–20 % based on chemotherapy regimen. The occurrence of severe or febrile neutropenia was within the range of that observed in previous studies of originator G-CSF. In addition, the safety profile of Zarzio® was consistent with that reported for originator G-CSF and the known safety profile of G-CSF. Initial concerns about the use of biosimilars, at least with regard to biosimilar G-CSFs, appear to be unfounded. Adoption of cost-effective biosimilars should help reduce healthcare costs and improve patient access to biological treatments.read more
Citations
More filters
Journal ArticleDOI
A systematic review of geographical variation in access to chemotherapy
TL;DR: Considerable variation in chemotherapy prescribing between healthcare boundaries has been identified and the absence of associations with natural geographical characteristics and receipt of chemotherapy suggests that local treatment habits, capacity and policy are more influential.
Journal ArticleDOI
Biosimilars: the science of extrapolation.
TL;DR: Concerns frequently raised in the medical community about the use of biosimilars in such extrapolated indications are addressed and the underlying scientific and regulatory decision making is explained including some real-life examples from recently licensed biosimilar.
Journal ArticleDOI
The changing landscape of biosimilars in rheumatology
Thomas Dörner,Vibeke Strand,Paul Cornes,João Gonçalves,László Gulácsi,Jonathan Kay,Tore K Kvien,Josef S Smolen,Yoshiya Tanaka,Gerd R Burmester +9 more
TL;DR: It is hoped that these lower costs will compensate for inequities in access to therapy based on economic differences across countries and establish pharmacovigilance databases across countries that are adequate to monitor long-term safety after marketing approval.
Journal ArticleDOI
Bevacizumab in Colorectal Cancer: Current Role in Treatment and the Potential of Biosimilars.
TL;DR: The current role of bevacizumab in the management of mCRC, the possible barriers associated with diminished access, and the potential bevaccizumAB biosimilars in development are reviewed.
Journal ArticleDOI
Biosimilars for the management of rheumatoid arthritis: economic considerations
TL;DR: The cost burden of RA is summarized and the potential role of biosimilars in reducing drug costs and increasing patient access to biologics is considered.
References
More filters
Journal ArticleDOI
2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours
Matti Aapro,Julia Bohlius,David Cameron,Lissandra Dal Lago,J. Peter Donnelly,Nora Kearney,Gary H. Lyman,Ruth Pettengell,Vivianne C. G. Tjan-Heijnen,Jan Walewski,Damien C. Weber,Christoph C. Zielinski +11 more
TL;DR: Clinical evidence shows that filgrastim, lenograstim and pegfilgrastIM have clinical efficacy and the use of any of these agents to prevent FN and FN-related complications where indicated and prophylactic G-CSF support is recommended.
Journal ArticleDOI
A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy.
M. D. Green,H. Koelbl,José Baselga,A. Galid,V. Guillem,Pere Gascón,Salvatore Siena,Roy I. Lalisang,Hellmut Samonigg,M. R. Clemens,V. Zani,B. C. Liang,J. Renwick,Martine Piccart +13 more
TL;DR: A single fixed dose of pegfilgrastim administered once per cycle of chemotherapy was comparable to multiple daily injections of fil grastim in safely providing neutrophil support during myelosuppressive chemotherapy.
Community code relating to medicinal products for human use
TL;DR: The main purpose of any regulation on the manufacture and distribution of medicinal products for human use should be to safeguard public health and should be achieved by means which do not hinder the development of the pharmaceutical industry or trade in medicinal products in the Community.
Journal ArticleDOI
Blinded, Randomized, Multicenter Study to Evaluate Single Administration Pegfilgrastim Once per Cycle Versus Daily Filgrastim as an Adjunct to Chemotherapy in Patients With High-Risk Stage II or Stage III/IV Breast Cancer
Frankie A. Holmes,Joyce O'Shaughnessy,Svetislava J. Vukelja,Stephen E. Jones,J. Shogan,Michael Savin,J. Glaspy,M. Moore,L. Meza,I. Wiznitzer,T.A. Neumann,L.R. Hill,B.C. Liang +12 more
TL;DR: A single injection of pegfilgrastim 100 microg/kg per cycle was as safe and effective as daily injections of filgrastims in reducing neutropenia and its complications in patients who received four cycles of doxorubicin 60 mg/m(2) and docetaxel 75 mg/M(2).
Journal ArticleDOI
Biosimilars: what clinicians should know.
Martina Weise,Marie-Christine Bielsky,Karen De Smet,Falk Ehmann,Niklas Ekman,Thijs J Giezen,Iordanis Gravanis,Hans-Karl Heim,Esa Heinonen,Kowid Ho,Alexandre Moreau,Gopalan Narayanan,Nanna Aaby Kruse,Gabriele Reichmann,Robin Thorpe,Leon van Aerts,Camille Vleminckx,Meenu Wadhwa,Christian Schneider +18 more
TL;DR: The members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) address issues about biosimilars and highlight the need for improved communication between physicians, learned societies, and regulators.
Related Papers (5)
Comparative cost-efficiency across the European G5 countries of various regimens of filgrastim, biosimilar filgrastim, and pegfilgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia:
Biosimilars: what clinicians should know.
Martina Weise,Marie-Christine Bielsky,Karen De Smet,Falk Ehmann,Niklas Ekman,Thijs J Giezen,Iordanis Gravanis,Hans-Karl Heim,Esa Heinonen,Kowid Ho,Alexandre Moreau,Gopalan Narayanan,Nanna Aaby Kruse,Gabriele Reichmann,Robin Thorpe,Leon van Aerts,Camille Vleminckx,Meenu Wadhwa,Christian Schneider +18 more