First Dornase Alfa Biosimilar Approved and Launched in Russia

This week, Russian drug maker Generium announced that it has received approval for—and has launched—its biosimilar dornase alfa in the Russian marketplace. Generium’s product is the first biosimilar dornase alfa biosimilar to be approved in any market worldwide.

The biosimilar, marketed under the name Tigerase, references Genentech’s Pulmozyme, a drug used in conjunction with other therapies to improve pulmonary function in patients with cystic fibrosis. Unlike many biologic therapies, which are infused or injected, dornase alfa, a recombinant human deoxyribonuclease I enzyme that selectively cleaves DNA, is administered by inhalation using a jet nebulizer.

“We believe patients will be able to maintain a higher quality of life on our dornase alfa inhalation solution,” said Dmitriy Kudlay, MD, PhD, chief executive officer of Generium, in a statement announcing the launch. “The orphan drugs market has been growing significantly over the last several years. Biotechnology, as a science, is developing rapidly, providing new products for the treatment of the most severe and rare diseases.”

The biosimilar was developed using proprietary technology from Selexis; the company’s platform uses novel human DNA-based elements that control the organization of chromatin across mammalian cells. These elements increase transcription rates of transgenes and allow for higher and more stable expression of recombinant proteins.

Selexis indicated in a statement that there are currently 122 clinical programs worldwide that are using its platform and that the dornase alfa biosimilar represents the sixth approval for a product developed using this technology.

Generium was also the first drug maker to receive approval for a biosimilar eculizumab (referencing Soliris), also in Russia. The rare disease drug was approved in April 2019 for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.