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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’.

Strategy for biosimilars in China

China is one of the largest pharmaceutical markets in the world, and has seen rapid growth in the biopharmaceuticals industry in recent years.  However, it is still lacking guidance when it comes to biosimilars. Authors Li and Tuan from the Shenyang Pharmaceutical University, China, discuss how this affects biologicals companies in China [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.

Regulating the safety of biosimilars

Clinical safety is critically important during the development of a biosimilar. An overview of the main aspects of safety assessment of biosimilars has been prepared to assist all those interested in this area of growing importance [1].

Adalimumab biosimilar has comparable pharmacokinetics to Humira

An adalimumab biosimilar (CHS-1420) from fledgling biotech company Coherus Biosciences (Coherus) has shown comparable pharmacokinetics in a pivotal clinical study.

The future of biosimilar use and regulation in Latin America

There is a growing uptake of biosimilars in Latin America, but this has not been accompanied by an increase in pharmacovigilance, training or regulation. To address this, an expert panel was put together to discuss the issues involved. The panel’s perspectives on the current status led to six major recommendations drawn up to enhance the safe use of biosimilars across the region [1].

ECCO survey highlights lack of confidence in biosimilar mAbs

In a presentation at the EuropaBio and the Alliance for Safe Biologic Medicines (ASBM) roundtable on naming, transparency and traceability for biosimilars [1], held on 18 March 2014 in Brussels, Belgium, Dr Alessandro Armuzzi presented results of a survey of European Crohn’s and Colitis Organisation (ECCO) members [2]. The results of the survey highlight the lack of confidence ECCO members have in biosimilars and the need for continued education.

Biosimilars in the treatment of chemotherapy-induced anaemia

A study of the use of epoetin biosimilars in the therapeutic management of anaemia secondary to chemotherapy in haematology and oncology has shown the biosimilars to be effective and well tolerated in the management of chemotherapy-induced anaemia in patients with solid tumours, lymphoma and myeloma [1].

Switching and extrapolation of subsequent entry biologics in Canada

The regulatory framework for biosimilars in Canada explains how their substitutability and/or interchangeability are governed in the country. Biosimilars, which are known as subsequent entry biologics (SEBs) in Canada, are regulated in line with guidance from the World Health Organization.

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