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Biosimilar trastuzumab candidate shows ‘similarity’ to Herceptin

Results of a phase III clinical study of Celltrion’s biosimilar trastuzumab candidate CT‑P6 demonstrated the ‘similarity’ of the efficacy and safety compared to the originator biological (Herceptin) in patients with HER2+ breast cancer [1].

US prescribers’ views on the naming and labelling of biologicals

The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey in which they asked 400 US physicians for their views on the labelling of biosimilar medicines, and a separate survey in which they asked another 400 US physicians for their views on the naming of biosimilar medicines [1]. All those surveyed were prescribers of biological medicines. The surveys were carried out in the run up to the release of guidance from the US Food and Drug Administration (FDA) on the non-proprietary naming of biological products.

Real world switching data for etanercept biosimilar Benepali

Real world evidence from a study of etanercept biosimilar Benepali (SB4) compared to Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept) have demonstrated ‘sustained efficacy and safety, and high acceptance and adherence in patients initiating treatment with Benepali (etanercept)’, according to Biogen.

Scientific rationale for extrapolation of cancer indications

Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medical condition. Once biosimilarity has been proven, biosimilars can also be approved for one or more additional indications held by the reference product, without the need for clinical data in those indications. Author Michinori Ogura from the Tokai Central Hospital, Gifu, Japan and colleagues from France and South Korea investigated the scientific rationale for extrapolation using the infliximab biosimilar CT-P10 as an example [1].

Pharmocovigilance of rituximab in Argentina

Novex is a rituximab medicamento biológico similar (similar biological medicines) approved in Argentina. According to Argentinian regulations such products need to implement an active pharmacovigilance programme. This requires regular reporting to the Argentinian regulatory agency Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Foods and Medical Devices; ANMAT).

Trastuzumab biosimilar could reduce breast cancer treatment costs

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Biosimilars and sustainability

Competition between brand-name biologicals and biosimilars has the potential to reduce future cancer costs, according to researchers from Italy [1].

Boehringer Ingelheim’s adalimumab biosimilar ‘equivalent’ to Humira

Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 14 June 2017 positive results from its pivotal phase III study of its candidate adalimumab biosimilar.

Biosimilar infliximab safe and effective in IBD

A systematic review and meta-analysis of Celltrion/Hospira’s infliximab biosimilar, Remsima/Inflectra found it to be safe and effective in the treatment of inflammatory bowel diseases (IBD) [1].

Infliximab biosimilar coming closer to interchangeability

Three studies presented at the Digestive Disease Week (DDW) 2017 have shown no significant differences in efficacy or safety endpoint. Two of the studies also specifically tested outcomes in patients switching from the originator infliximab product, Remicade, to the biosimilar version.

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