Xbrane's Ranibizumab Biosimilar Shows Equivalent PK and Tolerability to Lucentis

Swedish biotechnology company Xbrane Biopharma today announced that its ranibizumab biosimilar, referencing Lucentis, demonstrated an equivalent pharmacokinetic (PK) profile and equivalent tolerability to its reference in an in vivo study.

The study was conducted in rabbits, 1 group of which received a single bilateral intravetrial injection of the proposed biosimilar, and the other of which received an injection of the reference product. Tolerability was monitored using ophthalmologic examinations throughout the study, as well as by histopathology to check for potential microscopic inflammation.

Read more about biosimilar ranibizumab.

Eyes treated with the biosimilar did not show any ocular inflammation, and the biosimilar was well tolerated. Additionally, an equivalent pharmacokinetic profile between the 2 groups was demonstrated via serum measured in the vitreous body.

"We are very pleased with the result of this study as it demonstrates an equivalent tolerability and pharmacokinetic profile of [the biosimilar] compared to the reference product. This, combined with the excellent comparable in vitro analytical data previously announced, gives us full confidence ahead of the upcoming pivotal clinical equivalence trial." said Martin Åmark, CEO of Xbrane, in a statement.

Announcement of the positive results for the biosimilar, which Xbrane hopes to eventually sell under the name Xlucane, follows closely on the heels of Xbrane’s July 2018 announcement that it would partner with Stada to develop the biosimilar for the US, European, and other markets.

Under the agreement, each organization will contribute equally to development expenses an share profits from eventual commercialization. Xbrane will take the lead on development of the product until regulatory submissions to the European Medicines Agency (EMA) and the FDA have been made. After that time, Stada will be the prospective marketing authorization holder, and will be accountable for marketing of the product across all territories.

The organizations have already announced their phase 3 clinical trial of for the biosimilar, and have agreed on the study design with the EMA and FDA. The study will enroll patients with age-related macular degeneration at sites in 16 countries.

Xbrane has been making other steps forward in its biosimilar program, having announced in September 2018 that it would discontinue its development of generic drugs in order to free up resources for development of its ranibizumab biosimilar, as well as of biosimilar candidates of certolizumab pegol (Cimzia) and pegaspargase (Oncaspar).