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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's (EMA) 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].

Rituximab ‘similar biologic’ shows equivalent efficacy and safety

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

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

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

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'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

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].

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