Ranibizumab Updates: FDA approval of Roche’s Refillable Ocular Implant and FDA Acceptance of Bioeq’s BQ201 BLA

On October 22, 2021 Roche announced the FDA’s approval of its ranibizumab intravitreal injection, marketed as Susvimo.  Susvimo is a refillable ocular implant—requiring refills every six months—that continuously delivers medicine into the eye for the treatment of neovascular or wet age-related macular degeneration, a condition that can cause rapid and severe vision loss.  According to Roche, Susvimo offers patients as little as two treatments per year, whereas previous treatment options required eye injections as often as once a month.  The approval was based on positive results from the phase III Archway study, which showed equivalent vision improvement compared to monthly injections.  Of note, is that Susvimo was associated with a three-fold higher rate of endophthalmitis compared to monthly injections.

Additionally, on October 4, 2021 Polpharma Biologics Group announced that its joint venture Bioeq’s ranibizumab biosimilar BLA for BQ201 was accepted for review by the FDA.  Dr. Joerg Windisch, CEO of Polpharma Biologics Group commented, “This file acceptance is validation of the huge effort put in by the team at Bioeq and its partners to bring treatment choice and improved patient access to the US market.  It creates real promise for those who suffer from debilitating vision loss, including age-related macular degeneration.”  A target action date on the BLA by the FDA is expected in August 2022.  If approved, BQ201 will be exclusively commercialized by Coherus BioSciences in the United States.