On the heels of Samsung Bioepis’ recent approval of its ranibizumab biosimilar, comes the approval last week of Roche’s new delivery system for the reference product, a product called Susvimo™. The timing is a bit disconcerting, although pretty much everything about age-related wet macular degeneration treatment is disconcerting if not distressing.
Susvimo is a follow-on to Lucentis®, an attempt to address one of the principal objections to ranibizumab treatment—monthly injections into the eye. However, Roche’s solution sounds only marginally more palatable: surgery (with a local anesthetic) to put an object into the eye that remains in place permanently. It is refilled with ranibizumab every six months. Clinical efficacy with Susvimo seems to be about the same as when receiving intravitreal injections.
Not that monthly intravitreal injections are considered pleasant, but the placement of a rice-sized implant into the sclera may be even more off-putting. This is done in an operating room under aseptic conditions (similarly, with refill of the implant). Removal of the implant, if necessary, must also be done in the operating room.
Injecting Price into the Ranibizumab Issue
According to a report in Biopharma Dive, the cost of the implant and ranibizumab is $17,250 for the first year, and subsequent 6-month refills cost $8,000. This would put it at approximately 26% below the list price for 12 monthly injections of Lucentis (however, based on October 2021 ASP pricing, Lucentis costs $1,592 per month). Samsung Bioepis’ ranibizumab biosimilar Byooviz® will not be marketed until June 2022, and a price has not yet been announced. Coherus and its partners are expecting a mid-2022 approval on their own ranibizumab biosimilar. Currently, several manufacturers are developing biosimilars for aflibercept, including Viatris (which hopes to submit its 351[k] application this quarter) and Samsung Bioepis (SB15).
As one might suspect, Susvimo does have a significant list of adverse effects, such as conjunctival hemorrhage (in 72% of clinical trial participants), conjunctival hyperemia (26%), iritis (23%), eye pain (10%), and vitreous floaters (9%). Endophthalmitis occurred in 1.7% of patients administered the ranibizumab port system in the clinical study program, a rate that is more than threefold that for monthly intravitreal injections. The incidence of vitreous floaters is fourfold higher than with monthly injections. Iritis occurred in only 0.6% of patients in the clinical trials given intravitreal ranibizumab (a 38-fold difference). Within the first postoperative month, patients’ visual acuity worsened by 4 letters on standard eye charts, improving to a 2-letter decrease by the second postimplant month.
The introduction and success of Susvimo does not appear to be a slam dunk for Roche. Whereas the intravitreal injection is simple and painless, the port system installation and refills are more complex and carry greater risk. Most people are squeamish about sticking needles in their eyes in the first place. However, we can’t speak to any patient satisfaction research or patient preference surveys that may have been conducted by Roche.
From a payer perspective, this category is still wide open. Compounded bevacizumab is considerably less expensive than either injectable ranibizumab or the new port system. We have previously posted about the prospects for a manufactured form of injectable bevacizumab (with an updated date for its anticipated 351a filing of the first quarter 2022). And aflibercept (Eylea®) injections, which is the revenue leader in the category, may be given once every 8 weeks after the first 3 months, potentially offering some relief from monthly dosing.
Invitation to Step Therapy for Bevacizumab or Biosimilars?
Finally, Susvimo may not be considered a first-line alternative to bevacizumab, ranibizumab, or aflibercept. The ranibizumab port system prescribing information specifies that patients with age-related macular degeneration should be eligible for implantation only after receiving 2 monthly injections with another VEGF-inhibitor. This amounts to FDA-directed step therapy, which may somewhat limit the patient population for the new delivery system.
All in all, the factors affecting market dynamics in the ophthalmology biosimilar category continue to become more complex. Hopefully, the size of the market basket can accommodate the broad treatment options that will be available in just a couple of years.