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Additional clinical data for Cinfa’s pegfilgrastim biosimilar

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 2 November 2017 additional clinical data for its candidate pegfilgrastim biosimilar (B12019).

Switching failures with biosimilar etanercept

A study carried out by researchers from Denmark has found that switching from originator to biosimilar etanercept does not work for all patients [1].

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].

Biosimilars in oncology in Europe

In the European Union (EU), a legal framework for approving biosimilars was established back in 2003. This framework allows for biosimilars to be approved using an abbreviated pathway centrally via the European Medicines Agency (EMA) [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].