Russian biopharmaceutical company Generium JSC’s dornase alfa biosimilar inhalation solution has received marketing approval from Russian regulators for the treatment of cystic fibrosis, according to its partner Selexis, which developed the cell line. Genentech’s Pulmozyme dornase alfa inhalation solution has been approved in the US since 1993 and in Europe since 1994.
Generium CEO Dmitriy Kudlay commented, “We believe patients will be able to maintain a higher quality of life on our dornase alfa inhalation solution. 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.”
Selexis CEO Igor Fisch said, “This biologic’s market approval in Russia represents another major milestone for Selexis and we are pleased to recognize the work of Generium in delivering the fifth and sixth approvals using our SUREtechnology Platform.”
Read the Selexis and Generium press release.
