Biosimilars/Research
Reimbursement for oncology biosimilars in the US
How reimbursement issues for biosimilars might affect US oncologists was a subject discussed by Dr Rena Conti, Associate Professor of Health Policy and Economics in the Department of Paediatrics at the University of Chicago, USA [1].
Impact of follow-on biological products in the Brazilian health system
Cancer is an epidemic disease in the 21st century. However, despite consistent increases on its incidence worldwide, mortality rates have fallen, especially in developed countries [1, 2]. The victories mankind has achieved in the war against cancer result from advances in different fields, such as early diagnosis and better surgical, radiotherapeutic and systemic treatments.
Hospital specialists and pharmacists surveyed about biosimilars
Biological medicines are essential for many acute and chronic conditions, but their consumption differs widely among European countries [1, 2]. In contrast with the procedures for their approval [3], position papers from scientific societies suggest that biosimilars need to be tested in well-designed, randomized, controlled clinical trials, especially for extrapolation of indications [4, 5]. Nevertheless, switches with originators are becoming common and no serious adverse effects have been reported to date [6-8].
Positive phase III switching results for Celltrion’s infliximab biosimilar
Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) infliximab biosimilar (CT-P13) is shown to be comparable in efficacy and safety to Johnson & Johnson/Merck’s Remicade in switched inflammatory bowel disease patients, according to the South Korean biotechnology company.
Switching from reference infliximab to CT P13 in IBD patients
Argüelles-Arias and colleagues from the Hospital Universitario Virgen Macarena and the University of Seville in Spain carried out an observational study assessing the efficacy and safety of switching from Remicade to CT P13 in patients with inflammatory bowel disease (IBD) for up to 12 months [1].
Switching to biosimilar infliximab in IBD patients
Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options, such as CT‑P13 (Remsima/Inflectra), promises to improve the availability of biological therapy.
Biosimilars in oncology in the US
As part of the Affordable Care Act of 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allows for an abbreviated license pathway for the approval of biosimilars in the US. In light of continuing increases in healthcare costs, particularly for cancer drugs, use of biosimilars is increasingly being considered as a strategy for containing the cost of cancer care, according to Dr Gary Lyman of the Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA, USA [1, 2].
Loss of efficacy after switching to biosimilar infliximab in Behcet’s patients
Authors from the Division of Rheumatology at the Hospital of Prato, Italy report on three patients with Behçet’s disease that experienced disease relapses after switching from the originator infliximab, Remicade, to biosimilar infliximab [1].
Opportunities and challenges for biosimilars in oncology
The rapid increase in healthcare costs, particularly for cancer drugs, has had a major impact on providers, practices, payers and patients, according to Dr Gary Lyman of the Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA, USA [1, 2].
Phase III switching data support long-term efficacy and safety of rituximab biosimilar Truxima
Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) rituximab biosimilar (Truxima, CT-P10) is comparable to Roche’s MabThera/Rituxan, according to the South Korean biotechnology company.
