1st Biosimilar of Dornase Alfa Inhalation Solution for CF Approved in Russia, Companies Announce

A biosimilar of dornase alfa inhalation solution, with the same therapeutic activity as Pulmozyme, its reference therapy, was approved for use in Russia, Selexis and Generium Pharmaceutical announced. 

A biosimilar is like a generic formulation of an approved biological treatment in that it is clinically similar to its reference medicine. 

Named Tigerase, this is the first dornase alfa biosimilar made available anywhere in the world to treat people with cystic fibrosis (CF). “We believe patients will be able to maintain a higher quality of life on our dornase alfa inhalation solution,” Dmitriy Kudlay, MD, CEO of Generium, said in a press release. 

CF is caused by mutations of the CFTR gene that prevent cells from managing their salt and water balance. This imbalance triggers an accumulation of thick mucus in the organs that include the lungs, resulting in inflammation, repeated bacterial infections, increased scarring (fibrosis), and the possibility of respiratory failure.

Pulmozyme, marketed by Genentech, has been a standard therapy for CF patients since it was first approved in the 1990s. It is a synthetic version of the human deoxyribonuclease I enzyme (or rhDNase I), which selectively breaks down the long strands of DNA sequences that contribute to mucus thickening. Pulmozyme’s use makes the mucus thinner and easier to cough up. 

Used in combination with antibiotics, bronchodilators, and steroids, Pulmozyme can significantly improve airway flow and help prevent bacterial infections.

The new dornase alfa biosimilar was developed using Selexis’s SUREtechnology Platform, which uses the company’s proprietary, high-performance mammalian cell line (SURE CHO-M Cell Line) to generate higher yields and more stable production of recombinant proteins that can be used as therapeutic agents.

“There are currently 122 clinical programs in development utilizing our platform. The increasing number of Selexis-generated research cell banks used in clinical programs, and now a sixth marketed product, continue to validate the value of our scientific innovation,” said Igor Fisch, PhD, CEO of Selexis. “We are extremely proud of our ability to help our partners address complicated and intractable diseases by developing complex protein therapeutics faster, safer and more cost efficiently.”

Generium, a Russian biopharmaceutical company focused on diagnostic tools and therapies that include those for rare diseases, describes itself as the first worldwide to develop and market a biosimilar of dornase alfa. 

“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,” Kudlay said.