Under the terms of the agreement Biocad will supply biosimilar darbepoetin alpha APIs to Koçak Farma for five years. Biocad will give its Turkish partner exclusive rights to import the API, to produce the finished dosage forms locally, and to distribute and sell biosimilar darbepoetin alpha in Turkey. Koçak Farma, in turn, will have the rights for distribution and sales of finished dosage forms of the drug in Turkey under their own brand name.

Biocad’s drug is a biosimilar of Switzerland-based Roche’s blockbuster cancer medication Rituxan/MabThera (rituximab), which is indicated for the treatment of anaemia in chronic kidney failure and B-cell non-Hodgkin’s Lymphoma. Rituxan ranks among the top three biological drugs worldwide, with 2012 sales of about US$7 billion [1].

The biosimilar is currently undergoing phase III clinical trials and Biocad is preparing to obtain marketing authorization in Russia. Successful completion of the clinical trials will enable Biocad to launch the first Russian monoclonal antibody-based product on the international pharmaceutical market.

The agreement is expected to have a positive impact on the oncology market, with the biosimilar expected to be available at a much lower price than the originator biological.

The companies are also reported to be discussing full technology transfer to enable local manufacturing of the biosimilar darbepoetin alpha API.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Sandoz announces biosimilar rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 6]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-announces-biosimilar-rituximab

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