First Biosimilar of Soliris Approved for Use in Russia

Russia has approved for patient use the first biosimilar of Soliris (eculizumab), a monoclonal antibody for the treatment of atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH).

The product was created by the Selexis using its SUREtechnology Platform and will be marketed by Generium, the leading pharma company for orphan indications in Russia.

“This biologic’s market approval in Russia represents another major milestone for Selexis,” Igor Fisch, PhD, Selexis’ chief executive officer, said in a press release.

“There are currently more than 115 clinical programs utilizing the SUREtechnology Platform, including nine Phase 3 programs. The increasing number of Selexis-generated research cell banks used in clinical programs … validate our ongoing scientific innovation and our commitment to helping our partners address complicated and intractable diseases by developing complex protein therapeutics faster, safer and more cost efficiently,” Fisch added.

“The joint efforts of Russian, U.S. 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.

Eculizumab, the active ingredient in Soliris, is a recombinant human monoclonal antibody that specifically targets a component (protein C5) of the complement system — a part of the immune system that is chronically and uncontrollably activated in aHUS.

It halts the process of complement-mediated thrombotic microangiopathy — the formation of blood clots due to injury of small blood vessels — helping improve kidney function in aHUS patients.

The medicine is approved in more than 40 countries, including U.S., those across Europe, and Japan.

The technology employed to create the newly-launched biosimilar of eculizumab — Selexis’ SUREtechnology Platform — is a high-performance pipeline for the industrial production of therapeutic proteins and monoclonal antibodies (such as eculizumab) using mammalian cell-lines.

“This technology provides several key advantages over traditional approaches: Speed, Productivity, Stability, and Flexibility,” the company states.

Biosimilar medications are biological medicines highly similar to an already approved biological medicine, or medicines with active substances from biological sources.

Two important tools of this platform are novel human DNA-based elements to increase the production of recombinant (lab-made) proteins and the SURE CHO-M Cell Line, a cell-line derived from Chinese hamster ovary cells optimized for giving high yields of target proteins. Soliris is produced in a different kind of mammalian cell-line, derived from mice myeloma cells.