The Ministry of Health of the Russian Federation approved this week HERtiCAD, Russian drugmaker Biocad’s copycat version of Roche’s cancer monoclonal antibody Herceptin.
“This is the first trastuzumab biosimilar to be approved in Russia,” Biocad spokesperson Irina Kenyukhova told Biopharma-Reporter.com, but neither the first biosimilar on the market nor the first commercialised by the company which launched in Russia a filgrastim biosimilar in 2006, and a rituximab biosimilar in 2014.
“Biocad is definitely the leading company in Russia for monoclonal antibody biosimilar development,” she continued, adding the firm is also developing innovative biologics for the Russian such as its anti-IL 7 monoclonal antibody set to enter Phase II clinical studies.
While Kenyukhova did not reveal the price HERtiCAD, she said as part of the policy, “federal regulations require the first bioanalogue to be at least 10% cheaper than the original product.”
Russia is encouraging these cheaper copycats as part of its Pharma 2020 initiative – a policy implemented in 2011 by then-Prime-Minister, now-President, Vladimir Putin to help cut the burgeoning cost of healthcare, reduce the country’s reliance on imported products and encourage home-grown production.
According to Biocad, Russia’s government spent over 5bn rubles ($130m) in 2014 on Roche’s originator biologic.
“The development of the technology which made it possible to develop [our] trastuzumab biosimilar was covered under Pharma 2020 and the new products need to be produced locally,” Kenyukhova told us.
The world's first Herceptin biosimilar - CanMab - was approved in 2013 in India, with Biocon and Mylan launching the product at a 25% discount to the originator.
Biocad's main production facilities for mAbs and its head office are located in Saint Petersburg. Also Biocad has drug product production in Petrovo-Dalnee, just outside Moscow.
While Russia’s Ministry of Health has not developed its own official guidelines for biosimilar development Kenyukhova said “the regulation requirements are formulated in the federal law and are harmonized to the European medicine agency requirements.”