Ublituximab is very similar to Ocrevus (Roche Genentech) and neither is likely to be superior to the other for efficacy or safety. There are some subtle differences. They bind to different epitopes of the CD20 molecule. Also, ublituximab has been glycoengineered to enhance antibody dependent cellular cytotoxicity above the native monoclonal. There is no evidence whether these 2 differences between Ocrevus and ublituximab acting makes a difference in the clinical setting for treatment of MS. Both are associated with rapid destruction of the B cells (CD20 positive). Both should have an effect lasting the full 6 months. Over time it is possible that the subtle differences above will be found to matter, though most likely they will not. Ocrevus is a 5-6 B a year drug so there is potential to capture some of that market share.
There is 1 difference that may be more marketable - after the very first infusion, ublituximab can be infused more rapidly, over 60 minutes instead of 3 hours. That will allow more rapid turnover of an infusion chair which could make a difference at very busy centers (and possibly more of a difference if monoclonal treatments for Alzheimer's become common putting a strain on the sites). More importantly will be formulary placement and insurance coverage. Ublituximab will have to compete (and most likely will) with the good copay assistance and free drug programs that Genentech has in place for Ocrevus. TGTX has already hired reps, thought leader liaisons and MSLs.
Kesimpta, the third FDA approved anti-C20 mAb is self-injectable but also has similar risks and benefits. Rituximab is still used off label some for MS (much more for other neuro-immunologic disorders)
AI
