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FDA rejects Pfizer’s epoetin alfa biosimilar posted 19/07/2017

US pharma giant Pfizer announced on 22 June 2017 that the US Food and Drug Administration (FDA) had rejected its application...

Biocad registers rituximab similar biotherapeutic product in Bolivia and Honduras posted 19/07/2017

Russian biotechnology company Biocad announced on 6 June 2017 that it had obtained a marketing authorization for its rituxima...

EC approval for etanercept biosimilar Erelzi posted 07/07/2017

Sandoz, the generics division of Novartis, announced on 27 June 2017 that it had received European Commission (EC) approval f...

FDA rejects pegfilgrastim biosimilar from Coherus posted 07/07/2017

Coherus BioSciences (Coherus) announced on 12 June 2017 that it had received a complete response letter (CRL) from the US Foo...

EMA approval for adalimumab biosimilar Imraldi posted 04/07/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 June 2017 that it...

 

Research

US prescribers’ views on the naming and labelling of biologicals 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 f...

Real world switching data for etanercept biosimilar Benepali posted 14/07/2017

Real world evidence from a study of etanercept biosimilar Benepali (SB4) compared to Amgen/Pfizer’s arthritis blockbuster Enb...

Scientific rationale for extrapolation of cancer indications posted 14/07/2017

Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medic...

Pharmocovigilance of rituximab in Argentina posted 14/07/2017

Novex is a rituximab medicamento biológico similar (similar biological medicines) approved in Argentina. According to Ar...

Trastuzumab biosimilar could reduce breast cancer treatment costs posted 04/07/2017

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. I...

 

General

Biosimilars of trastuzumab posted 18/07/2017

Last update: 14 July 2017Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor rec...

Similar biotherapeutic products approved and marketed in Latin America posted 14/07/2017

Last update: 14 July 2017Regulation of similar biotherapeutic products in Latin America varies widely among differe...

Biosimilars approved in Europe posted 14/07/2017

Last update: 7 July 2017In the European Union (EU), a legal framework for approving biosimilars was established in 2003....

Biosimilars of bevacizumab posted 14/07/2017

Last update: 7 July 2017Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new b...

Biosimilars of pegaspargase posted 30/06/2017

Pegaspargase is a modified enzyme. It is a form of L-asparaginase which has undergone PEGylation. It is used as an anticancer...

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