Russia Regulators Approve First mAb Biosimilar
The Russia Ministry of Health has issued a positive opinion for AcellBia, BIOCAD’s rituximab biosimilar. AcellBia is the first mAb biosimilar to be approved by Russian regulators.
The positive opinion is based on results from a multi-center, randomized clinical study comparing safety, efficacy, pharmacokinetics, and pharmacodynamics of BCD-020 (rituximab biosimilar by BIOCAD) to the reference rituximab. The rituximab biosimilar is intended as treatment for B-cell lymphoma. BIOCAD’s registration clinical study for AcellBia involved over 30 centers in Russia, India, Ukraine, and the South African Republic.
Research Center for Expertize of Medicinal Products at the Russian Ministry of Health experts determined there were no significant differences between BIOCAD’s rituximab biosimilar and the reference drug. Other independent analytical studies supported the quality and similarity of positive opinion for AcellBia.
Dmitry Morozov, founder and CEO of BIOCAD, said that the Russian government and patients spent more than $300 million on MabThera, the leading drug in the Russian healthcare market. “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 also said domestic capacity for producing high quality and high value biosimilars will help make drugs cheaper. It will also aid the Russian healthcare sector to be less dependent on foreign drug imports.
The company announced that it is currently wrapping up clinical trials of two more mAb biosimilars bevacizumab and trastuzumab to Herceptin and Avastin by Hoffmann-La Roche respectively. BIOCAD reported that it has ten more mAb-based biosimilar and original drugs set for development in its pipeline.