Biosimilars/Research

US biosimilar uptake in the light of Obamacare

Biosimilars/Research | Posted 05/12/2014

A literature review by researchers at Tufts University in the US concludes that market uptake of biosimilars in the US will depend on regulatory policies, including the smoothing out of issues concerning the country’s Food and Drug Administration (FDA) regulatory pathway [1, 2]. The review comes in the light of a new approval pathway for biosimilars established as part of the US Government’s Affordable Care Act, more widely known as Obamacare.

Use of biosimilars in rheumatology

Biosimilars/Research | Posted 05/12/2014

In order to issue a position statement on the use of biosimilars in rheumatic diseases, the Sociedade Portuguesa de Reumatologia (Portuguese Society of Rheumatology) carried out two systematic literature reviews: one on clinical trials and one on international position papers for biosimilars [1].

Rituximab ‘similar biologic’ shows equivalent efficacy and safety

Biosimilars/Research | Posted 02/05/2014

A retrospective analysis of cancer patients who received either originator or ‘similar biologic’ rituximab chemotherapy showed comparable efficacy and safety [1].

Patient access to rituximab in emerging markets

Biosimilars/Research | Posted 19/09/2014

A Pfizer-sponsored study looking at access to the oncology treatment rituximab has revealed that use of this important drug would increase across all therapy types and markets if a biosimilar was available. A rituximab biosimilar would have the greatest impact in Brazil, Mexico and Russia.

Biosimilar trastuzumab candidates in phase III development

Biosimilars/Research | Posted 09/05/2014

The introduction of Herceptin (trastuzumab) revolutionalized the treatment of breast cancer. Prior to its introduction there were few treatment options available to women with human epidermal growth factor receptor 2-positive (HER2+) breast cancer.

Comparison of biosimilar filgrastim versus other G-CSF formulations after autologous stem cell transplantation

Biosimilars/Research | Posted 28/11/2014

Introduction
Only limited data have been so far published about the use of biosimilar filgrastim in haematologic recovery after autologous stem cell transplantation (ASCT). Despite the limitation due to retrospective analysis performed on a limited number of patients, all these studies suggest a substantially similar efficacy of biosimilar products, when compared to originators in the febrile neutropenia prophylaxis of lymphoma and myeloma patients post-ASCT. The aim of this study was to compare the biosimilar filgrastim Zarzio with the other available formulations of granulocyte colony-stimulating factor (G-CSF) in terms of efficacy and safety [1].

Extrapolation of indications in biosimilars: filgrastim

Biosimilars/Research | Posted 21/11/2014

Extrapolation* of indications for biosimilars is a contentious issue and has been met with concern by physicians. Members of the European Medicines Agency's (EMA) Biosimilar Medicinal Products Working Party (BMWP) address these concerns using extrapolation of indications in biosimilar filgrastim as an example [1].

Biosimilars: when indications can be extrapolated

Biosimilars/Research | Posted 14/11/2014

Extrapolation* is already a well-established and accepted scientific and regulatory principle, according to members of the European Medicines Agency's (EMA) Biosimilar Medicinal Products Working Party (BMWP) [1].

Predicting the response of diabetes patients to biosimilar insulin

Biosimilars/Research | Posted 07/11/2014

For patients with type 1 diabetes, the quality of the insulin they take is a matter of life and death. The situation is similar for patients with type 2 diabetes. The question is what will these patients think about switching from their current brand-name insulins to new biosimilar versions? The question is important right now with the imminent arrival of biosimilar insulins on the market.

Biosimilars: similar but not identical

Biosimilars/Research | Posted 07/11/2014

One reason for distrust among physicians over using biosimilars in extrapolated* indications could be the fact that it is frequently cited that biosimilars are ‘similar but not identical’ compared to small molecule generics, which are often referred to as ‘identical’.