Biocad Wins Rituximab Patent Challenge, Plans to Enter the European Market

Russian biosimilar developer Biocad has won a legal battle that will allow it to move forward with its rituximab biosimilar.

The Pharma Letter reports that Biocad triumphed in a patent dispute over rituximab with Swiss drug developer and maker of the reference rituximab (Rituxan, MabThera), Roche. The Russian government’s Chamber for Patent Disputes announced that Roche—Genentech’s patent covering the use of rituximab in rheumatoid arthritis was invalid. The ruling clears the way for Biocad to produce and commercialize a biosimilar of the anti–tumor necrosis factor agent that is used in the treatment of both cancer and rheumatologic diseases.

In June, Biocad gained authorization to market the biosimilar rituximab as Usmal in Bolivia and Honduras, and has already begun selling the drug in 7 other markets, including Kazakhstan, Vietnam, and Sri Lanka.

Biocad also announced its intentions to enter the European marketplace with both its innovator and biosimilar products, and said that it expects to receive marketing authorization from the European Medicines Association beginning in 2021. According to Biocad, the company is ready to provide dossiers of its medicines that align with the International Council for Harmonization Common Technical Document format. In May, Biocad took its first steps toward European market entry when it established a new Eurozone presence in Turku, Finland. Biocad plans to invest €25 million (approximately $28 million) in Finland’s Turku region over the next 7 years as it continues to develop products for the European market.

Despite its legal gains in Russia and its eye on global expansion, Biocad still faces hurdles to entering the United States market; in 2016, Biocad filed suit in a New York district court alleging that competitor Roche and other drug makers were engaged in an anticompetitive scheme that blocked Biocad from entering the US oncology drug marketplace. Biocad alleged that its competitors were increasing the prices of their drugs in the United States while selling the same products at deep discounts in Russia.

The judge dismissed the case, saying that US antitrust laws do not extend to conduct in Russia, and the effect of the activities in Russia on the United States market were too attenuated for the court to have jurisdiction over the claims.