Biosimilars

US prescribers’ views on the naming and labelling of biologicals

Biosimilars/Research | Posted 14/07/2017

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

Biosimilars/Research | Posted 14/07/2017

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.

FDA rejects Pfizer’s epoetin alfa biosimilar

Biosimilars/News | Posted 14/07/2017

US pharma giant Pfizer announced on 22 June 2017 that the US Food and Drug Administration (FDA) had rejected its application for approval of its epoetin alfa biosimilar.

Biocad registers rituximab similar biotherapeutic product in Bolivia and Honduras

Biosimilars/News | Posted 14/07/2017

Russian biotechnology company Biocad announced on 6 June 2017 that it had obtained a marketing authorization for its rituximab ‘similar biotherapeutic product’ in Bolivia and Honduras under the trade name Usmal.

Scientific rationale for extrapolation of cancer indications

Biosimilars/Research | Posted 07/07/2017

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 rituximab biosimilar CT-P10 as an example [1].

EC approval for etanercept biosimilar Erelzi

Biosimilars/News | Posted 07/07/2017

Sandoz, the generics division of Novartis, announced on 27 June 2017 that it had received European Commission (EC) approval for its biosimilar etanercept product Erelzi.

FDA rejects pegfilgrastim biosimilar from Coherus

Biosimilars/News | Posted 07/07/2017

Coherus BioSciences (Coherus) announced on 12 June 2017 that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its candidate pegfilgrastim biosimilar, CHS‑1701.

Pharmocovigilance of rituximab in Argentina

Biosimilars/Research | Posted 07/07/2017

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).

EMA approval for adalimumab biosimilar Imraldi

Biosimilars/News | Posted 30/06/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 June 2017 that it had recommended granting marketing authorization for the adalimumab biosimilar Imraldi from Samsung Bioepis.

Trastuzumab biosimilar could reduce breast cancer treatment costs

Biosimilars/Research | Posted 30/06/2017

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.