The trastuzumab biosimilar, to be marketed under the trade name HERtiCAD™, is the first trastuzumab biosimilar to receive authorization from the Russian regulatory body.
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 Herceptin (F. Hoffmann-La Roche Ltd).
BIOCAD started development of trastuzumab biosimilar in 2010 in the context of a federal innovative project that was approved by the Presidential Commission on Modernization and Technological Advancement simultaneously with other two biosimilars of rituximab and bevacizumab, which were also registered in Russia in 2014 and 2015, respectively. 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 2014, world sales of the original drug trastuzumab were over $6.8 billion. Russia’s government spent over 5 billion rubles (130 mln USD) for original medicine and there are still uncovered medical need of Russian patients in trastuzumab. The approval of trastuzumab biosimilar 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.
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 trastuzumab biosimilar is produced in a new, ultra-modern Neudorf facility set in a special economic development district outside St. Petersburg. The company has already registered two other biosimilars of rituximab and bevacizumab. Rituximab was the first mAb biosimilar approved in Russia under the trade name Acellbia™ and by now used in more than 6 000 patients with non-Hodgkin's lymphoma and chronic lymphoid leukemia under federal reimbursement.