ST. PETERSBURG, Russia -- (BUSINESS WIRE) -- The rituximab biosimilar, to be marketed under the trade name AcellBia™, is the first mAb biosimilar to receive a positive opinion from the Russian regulatory body.
The Russian MoH’s positive opinion on AcellBia™ is based on the results of a 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 at the end of 2011; by mid-2012, it already involved more than 30 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 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, 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 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.
About CJSC BIOCAD
Based in St. Petersburg, Russia, joint-stock company BIOCAD is a leading Russian private biopharmaceutical company, specializing in the research, development and manufacture of generic, biosimilar, and innovative drugs. BIOCAD works to provide more affordable therapeutic proteins and small-molecule generics to patients who previously had limited access to high-value drugs in the areas of oncology, autoimmune, and infectious diseases.