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) to the innovator Herceptin (F. Hoffmann-La Roche Ltd).

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.

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.