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News

FDA accepts application for Celltrion/Teva’s rituximab biosimilar posted 11/08/2017

South Korean biotechnology company Celltrion and partner Israeli generics giant Teva Pharmaceuticals (Teva) announced on 29 J...

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...

 

Research

Biosimilar trastuzumab candidate shows ‘similarity’ to Herceptin posted 11/08/2017

Results of a phase III clinical study of Celltrion’s biosimilar trastuzumab candidate CT‑P6 demonstrated the ‘similarity’ of...

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...

 

General

Setback in Biocon/Mylan’s biosimilar programme after GMP inspection posted 11/08/2017

Biocon/Mylan’s biosimilar programme has hit a stumbling block after failing an inspection by the French inspecting authority...

Biosimilars of infliximab posted 11/08/2017

Last update: 11 August 2017Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It...

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....