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Extrapolation of indications in biosimilars: epoetin

Despite a stringent approval process, acceptance of biosimilars in the medical community continues to be low, and especially in extrapolated* indications. Members of the European Medicines Agency (EMA)’s Biosimilar Medicinal Products Working Party (BMWP) address these concerns using extrapolation of indications in biosimilar epoetin as an example [1].

Non-biological complex drug concept: experiences with iron sucrose and low molecular weight heparin

When the patent of a classical small molecule drug expires, generics may be marketed if their therapeutic equivalence to the originator drug has been established. The therapeutic equivalence of a drug includes both pharmaceutical equivalence and bioequivalence and do not require formal clinical efficacy and safety studies. The demonstration of therapeutic equivalence then allows for the interchangeability of the generic and originator drug. This approach has so far only been applied to products that can be fully characterized. For more complex molecules, which are difficult to characterize, such as proteins, the demonstration of bioequivalence requires an alternative approach.

US biosimilar uptake in the light of Obamacare

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

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].

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

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

Extrapolation* of indications for biosimilars is a contentious issue and has been met with concern by physicians. Members of the European Medicines Agency (EMA)’s 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

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

Predicting the response of diabetes patients to biosimilar insulin

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

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’.

Improved labelling sought for biosimilar acceptance

The terms of approval for every biosimilar and its reference product must be made clearer, argue the European Biopharmaceutical Enterprises (EBE) [1]. The development of biosimilar regulatory pathways worldwide has been led by the European Medicines Agency (EMA) [2], but EMA’s information-driven stepwise approach is only reflected in a single section of the product labelling for healthcare professionals and patients, which so far has followed a generic approach in Europe.

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