Xbrane’s lead biosimilar candidate is a ranibizumab product (referencing Lucentis), developed in collaboration with Stata, that is moving into a pivotal clinical trial. The study will enroll patients with wet age-related macular degeneration across 16 countries.
Xbrane Biopharma has announced that it will shift its focus from generic drugs to biosimilars. “The board of directors of Xbrane has decided to dedicate the absolute majority of the company's development resources to biosimilars going forward,” the drug maker announced in a statement on September 10.
As part of Xbrane’s shift to biosimilars, the company will only pursue further development of its generic long-acting risperidone, leuprolide, exenatide, and octreotide products if additional resources become available internally or via strategic partnerships. It will, however, continue to develop its long-acting triptorelin injectable, a treatment for advanced prostate cancer. The freed-up resources from generic development will allow the company to pursue its pipeline of biosimilars.
Xbrane’s lead biosimilar candidate is a ranibizumab product (referencing Lucentis), developed in collaboration with Stata, that is moving into a pivotal clinical trial. The study will enroll patients with wet age-related macular degeneration across 16 countries. In July 2018, Xbrane and Stada announced their development agreement for the product, under which each organization will contribute equally to development expenses and share profits from commercialization of the proposed biosimilar. Additionally, Stada agreed to make an upfront payment to Xbrane of approximately $8.7 million to fund development.
Also under development by Xbrane are a certolizumab pegol product (referencing Cimzia) and a pegaspargase product (referencing Oncaspar) for the treatment of acute lymphocytic leukemia.
The company says that it is also beginning development of 2 products that have patents expiring between 2026 and 2028. Said chairman Anders Tullgren, “We see multiple attractive opportunities to address and we have decided to develop  biosimilars on  fast growing biologics with a current combined global sale well above [$5 billion] with patent expiration 2026-2028. Now is the right time to initiate development of biosimilars to these biologics and we see the opportunity to be ahead of the game and to be amongst the first to launch."