Biosimilars
FDA approves follow-on insulin lispro Admelog
Pharma giant Sanofi announced on 11 December 2017 that the US Food and Drug Administration (FDA) had approved its follow-on version of Eli Lilly’s Humalog (insulin lispro).
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].
FDA approves biosimilar infliximab Ixifi
Pfizer announced on 13 December 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Regicide (infliximab).
Bevacizumab similar biologic launched in India
India-based biologicals specialist Biocon announced on 23 November 2017 the launch of its product Krabeva, a ‘similar biologic’ of bevacizumab, in India.
FDA approves trastuzumab biosimilar Ogivri
On 1 December 2017, the US Food and Drug Administration (FDA) approved its first trastuzumab biosimilar.
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].
Roche sues Pfizer over Herceptin biosimilar
Switzerland-based drug giant Roche has sued pharma giant Pfizer for patent infringement on its blockbuster breast cancer drug Herceptin (trastuzumab) in an attempt to block competition from Pfizer’s trastuzumab biosimilar.
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.
EC publishes biosimilar Q&A document for patients in 23 languages
On 29 November 2017, the European Commission (EC) published a patient-focused Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public.
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].
