Biocad's Rituximab Biosimilar Enters Latin America; Roadblocks Remain in the US

Earlier this month, Biocad obtained a marketing authorization for its rituximab biosimilar in Bolivia and Honduras. The biosimilar product, which will be marketed under the trade name USMAL, will be available to patients within months.

Currently, only reference rituximab treatments (Roche’s Rituxan and MabThera) are available in the Bolivian and Honduran markets. In its official statement, Biocad says that competitive pricing for its product will effectively double the availability of rituximab in the 2 nations. The next step for Biocad’s involvement in the Latin American markets, the company says, is to launch its trastuzumab and bevacizumab biosimilars, already being marketed and distributed in other nations.

Biocad is currently registering its rituximab biosimilar in other countries in the region, and expects to have received 2 more marketing authorizations by the end of the year. The firm has already shipped the rituximab biosimilar to 7 other countries worldwide, including Kazakhstan, Vietnam, and Sri Lanka.

This latest move is a step toward even greater expansion for the Russian biotechnology company; earlier this year, Biocad signaled its intentions to enter the European market through establishing a partnership in Finland. Biocad plans to invest €25 million ($28 million) in Finland’s Turku region over the next 7 years as it continues to develop products for the European market.

With such a focus on global expansion—and a deepening hunger for affordable biologics in the US—Biocad has its eye on FDA approval to gain a share of the US biologics marketplace. Yet, according to Biocad, anti-competitive practices from innovators may put such a potential US market entry in jeopardy. In 2016, Biocad filed a lawsuit against Roche in the federal court in New York, saying that the innovator had attempted to drop its prices for several reference oncology drugs in Russia (purportedly to thwart competition from Biocad’s biosimilar products) while simultaneously raising prices for the same drugs in the United States.

“While Roche and Genentech keep raising prices in the US, they engage in predatory pricing in Russia, where [they] sell such drugs at a loss—all to destroy [Biocad] and prevent it from entering the US market with cheaper biosimilars,” Biocad alleged. Roche, for its part, called the lawsuit “frivolous.”