Biocad's Herceptin biosimilar approved in Russia

20 January 2016
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Leading Russian biotech firm Biocad has received approval for the first biosimilar trastuzumab from Russia’s Ministry of Health.

The trastuzumab biosimilar will be marketed under the trade name HERtiCAD. It is a biosimilar of Swiss pharma giant Roche’s (ROG: SIX) blockbusterHER2-positive breast cancer medicine, Herceptin, sales of which in the first nine months of 2015 grew 10% to 4.88 billion francs ($4.9 billion).

The market authorization of the trastuzumab biosimilar (fully developed and produced by Biocad) followed the results of a randomized multicenter clinical study comparing the pharmacokinetics, immunogenicity, safety, and efficacy of BCD-022 (trastuzumab biosimilar by Biocad) to the innovator product Herceptin.

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