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EC approval for trastuzumab biosimilar Ontruzant Biosimilars/News | Posted 01/12/2017

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 20 November 2017 that it had received European Commission (EC) approval for...

Switching from reference infliximab to CT P13 in IBD patients Biosimilars/Research | Posted 01/12/2017

Argüelles-Arias and colleagues from the Hospital Universitario Virgen Macarena and the University of Seville in Spain carried out an observational study assessing the efficacy and safety of switchi...

South Africa approves first non-originator biological Biosimilars/News | Posted 01/12/2017

South Africa’s Medicines Control Council (MCC) has approved the country’s first non-originator biological, filgrastim, from Teva Pharmaceutical Industries (Teva).

Drugmakers waking up to potential value of branded generics Generics/News | Posted 01/12/2017

Pharma companies are making a move into what may become a lucrative sector – branded generics. The concept is simple – take a generic drug, repackage it and add marketing and hey presto you have a...

Merck KGaA and Samsung BioLogics extend strategic alliance Pharma News | Posted 01/12/2017

German drugmaker Merck KGaA (Merck Group) announced on 1 November 2017 that it had signed a ‘Memorandum of Understanding (MoU) with Samsung BioLogics for a strategic alliance on biopharmaceutical m...

Generic metformin bioequivalent in healthy volunteers in Nigeria Generics/Research | Posted 01/12/2017

Researchers from Nigeria’s Obafemi Awolowo University have found generic metformin sourced in the country to be ‘not inferior’ to originator metformin [1].

Biosimilars in oncology in Europe Biosimilars/Research | Posted 01/12/2017

In the European Union (EU), a legal framework for approving biosimilars was established back in 2003. This framework allows for biosimilars to be approved using an abbreviated pathway centrally via...

Biosimilars of palivizumab Biosimilars/General | Posted 01/12/2017

Palivizumab is a humanized monoclonal antibody. It targets the fusion protein of respiratory syncytial virus (RSV) inhibiting its entry into the cell and thereby preventing infection. Palivizumab i...