Biocad’s biosimilar rituximab receives approval in Russia

April 24, 2014 9:11 AM

The rituximab biosimilar which will be marketed under the trade name AcellBia, is the first mAb biosimilar to receive positive opinion from the Russian regulatory body.

The Russian MoH’s positive opinion on AcellBia is based on the results of randomized multicenter clinical study comparing the pharmacokinetics, pharmacodynamics, safety, and efficacy of BCD-020 (rituximab biosimilar by BIOCAD) to the innovator rituximab. The registration clinical study of rituximab biosimilar in CD20-positive indolent non-Hodgkin’s lymphoma patients started in Russia in the end of 2011, and by mid-2012 it already involved over thirty centers in Russia, Ukraine, India, and South African Republic.

After exhaustive analyses of the clinical trial efficacy and safety data in patients with B-cell lymphoma, the experts of the Research Center for Expertize of Medicinal Products at the Russian Ministry of Health arrived at conclusion on the absence of meaningful differences between BIOCAD’s rituximab biosimilar and the originator drug. Independent analytical studies confirmed the new drug’s outstanding quality.

BIOCAD started work on rituximab biosimilar in 2010 in the context of a federal innovative project that was approved by the Presidential Commission on Modernization and Technological Advancement. The scope of the project included in-house development of mAb manufacturing technology, comprehensive characterization of developed biosimilars, comparative non-clinical and clinical studies.

Mr. Morozov further elaborated that “In 2013 world sales of the original drug were over $7.5 billion. On the Russian market MabThera is number one product – in 2012 Russia’s government and patients spent over $300 million on MabThera. The approval of AcellBia is definitely good news for patients who previously had limited access to advanced therapeutics, and in particular for those hindered by the extra high cost of antibody biopharmaceuticals. We believe that the first mAb biosimilar approval by the Russian Health Ministry will turn a new page in availability of mAb therapeutics in the Russian public health sector.”

BIOCAD’s founder expressed hope that domestic capacity for production of high-quality, high-value biosimilars for treating diseases with the most profound social impacts will not only make the drugs more affordable, but will also help make the Russian healthcare sector less dependent on foreign imports.

BIOCAD’s rituximab biosimilar is produced in a special economic development district outside of St. Petersburg.  BIOCAD is also finishing clinical trials of two more mAb biosimilars, bevacizumab and trastuzumab (biosimilars of Herceptin and Avastin by Hoffmann-La Roche), that will be produced at the same facility. The company has ten more mAb-based biosimilar and original products in the pipeline.

Source: BIOCAD press release


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