Generium’s biosimilar for Soliris (eculizumab), a monoclonal antibody (mAb) indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome, has been approved after development with Selexis.
Soliris was created by Alexion and has been approved in the U.S., EU, Japan, and other countries as a first line treatment. Eculizumab from Generium will be the first biosimilar for Soliris.
The drug was created by Moscow-based Generium, which partnered with Selexis for the use of its SureTechnology platform to generate the biological product.
Selexis’ platform is based on the company’s Selexis Genetic Elements (SGE) which is comprised of elements that control the organization of chromatin across mammalian cells. According to Selexis and Generium, the use of SGE enables higher and more stable expression of recombinant proteins through increased transcription rates.
Additionally, Selexis uses a CHO-M cell line comprised of mammalian cell line derived from CHO-K1 cells. The genome of the CHO-M Cell Line has been fully sequenced to characterize the sequence of the transgene, identify transgene integration loci, and document the monoclonality of cell populations.
The SureTechnology uses the Sure CHO-M cell line for the production of therapeutic recombinant proteins and monoclonal antibodies, such as with Generium’s eculizumab biosimilar.
Igor Fisch, CEO of Selexis told us, “Like small-molecule generics, the value proposition of biosimilars is a reduction in the cost of goods. Selexis’’ CHO-M Cell Line, containing Selexis SGEs, generates high quantities of quality product, stable over time and under high-cell-density conditions in a large bioreactor.”
Fisch also told us that, in the development of the biosimilar, stable and high-expressing research cell banks were generated at the company’s headquarters in Geneva, Switzerland, using the SureTechnology platform and cell line.
Selexis transferred the research cell banks, feed strategy, and scale-up process to Generium to manufacture the biosimilar.
This is the fifth biological product generated by the platform that has been approved for marketing. Currently, there are 115 clinical programs using the SureTechnology platform, nine of which are in Phase III trials.