BIOCAD announces the final approval of rituximab biosimilar in Russia

May 15, 2014 9:45 AM

The rituximab biosimilar, to be marketed under the trade name AcellBia, is the first mAb biosimilar which received the affirmative decision on registration from the Ministry of Health of the Russian Federation (registration certificate number LP 002420).

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 (MabThera by Hoffmann-La Roche). The registration clinical study of rituximab biosimilar in CD20-positive indolent non-Hodgkin’s B cell lymphoma patients started in Russia at the end of 2011; by mid-2012, it had already involved more than 30 clinical centers in Russia, Ukraine, India, and the 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 a conclusion on the absence of substantive differences between BIOCAD’s rituximab biosimilar and the originator medicinal product. Independent analytical studies confirmed the new drug’s outstanding quality.

BIOCAD started to work on rituximab biosimilar in 2010 as a part of the 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, and comparative non-clinical and clinical studies.

Dmitry Morozov, founder and CEO of BIOCAD, said, “In 2013, world sales of the original drug were over $7.5 billion. On the Russian market, MabThera is the No. 1 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 the availability of mAb therapeutics in the Russian public health sector.”

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

BIOCAD’s rituximab biosimilar is produced in a new, ultra-modern Neudorf facility set in a special economic development district outside 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 10 more mAb-based biosimilar and original products in the pipeline.

 

Source: Biocad press release

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