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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.

Study results show safety of switching to biosimilar infliximab

US-based Epirus Biopharmaceuticals (Epirus) announced on 23 September 2014 positive week 58 follow-up data from its global phase III study for its biosimilar infliximab (BOW015). Results of the open label phase, which was carried out in rheumatoid arthritis patients, demonstrated comparable safety and efficacy compared to the originator product (Remicade).

Extrapolation for biosimilars

Regarding extrapolation* of indications for biosimilars, the European Medicines Agency (EMA) has stated that ‘if clinical similarity can be shown in a key indication, extrapolation of efficacy and safety data to other indication(s) of the reference product may be possible’ under certain conditions [1].

Biosimilar bevacizumab similar to Avastin in preclinical assessments

Preclinical assessments have demonstrated the similarity of biologicals major Amgen’s biosimilar bevacizumab candidate (ABP 215) to Avastin [1].

Mobilization of stem cells by biosimilar Nivestim and Neupogen

Comparison of biosimilar granulocyte colony-stimulating factor (G-CSF), Nivestim and originator G-CSF, Neupogen (filgrastim), showed no statistical differences when used for the mobilization of peripheral blood stem cells in patients treated for haematological malignancies [1].

Phase III study of biosimilar adalimumab meets primary endpoint

Biologicals major Amgen announced on 8 October 2014 the first late-stage data from its biosimilars programme. Primary efficacy analysis from a phase III trial of Amgen’s adalimumab biosimilar (ABP 501) compared with Humira (adalimumab) has demonstrated ‘clinical equivalence’.

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