Russian Drug Maker Gains World's First Approval for Biosimilar Eculizumab

Russian drug manufacturer Generium Pharmaceutical, which specializes in orphan drugs, announced yesterday that it has received Russian marketing approval for its biosimilar eculizumab, referencing Soliris, the most expensive orphan drug in Russia.

The biosimilar was authorized for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), which is a rare and life-threatening disease of the blood characterized by destruction of red blood cells by the complement system, and atypical hemolytic uremic syndrome (aHUS), which is an extremely rare, life-threatening, and progressive condition caused by the uncontrolled activation of the complement system.

“The joint efforts of Russian, US, and Swiss scientists have made it possible to achieve significant progress in the development of high-tech medicines for the treatment of rare diseases such as a PNH and aHUS, with the economic benefits of local production,” Dmitriy Kudlay, chief executive officer of Generium, said in a statement announcing the product’s approval.

While Generium is the first to gain approval for its biosimilar, it is by no means the only Russian drug developer with an interest in eculizumab; Biocad recently announced that it has begun clinical studies for its own biosimilar eculizumab candidate referencing Soliris.

Biocon’s study of the eculizumab biosimilar in patients with PNH, marking a foray into ultrarare diseases, is a new direction for the Russian biosimilar developer; thus far, Biocad has focused on the development of more widely used biosimilars, such as filgrastim, bevacizumab, trastuzumab, infliximab, and adalimumab.

Increasingly, developers see ultrarare diseases as viable markets for their biosimilars, due in part to the fact that patients with rare diseases are taking even the highest-priced drugs at increasing volumes; Alexion, which makes the reference eculizumab product, recently revealed that its sales volume for the ultra—high-cost drug had increased by 24% in 2018 versus 2017, driven in part by its recently granted indication for the treatment of the rare disease myasthenia gravis. Alexion is also seeking another new indication for the innovator product in another rare disease, anti-aquaporin-4 auto antibody-positive neuromyelitis optica spectrum disorder.