In what is shaping up to be the summer of the biosimilars in retina, two products that reference Lucentis are taking significant steps to enter the U.S. market. Byooviz—pronounced bio-vizz—had its commercial launch July 1, after receiving Food and Drug Administration approval last year. And in August, the FDA is poised to act on an application for CHS-201 that Coherus Biosciences submitted last year.
Byooviz hits the market at $1,130 for a single-use 0.5-mg vial, Jillian Scaife, senior director of marketing access for U.S. biosimilars at Biogen, tells Retina Specialist. That’s about 40 percent lower than what Global Data reports as the list price of $1,850 for Lucentis (ranibizumab, Genentech/Roche).
Biogen seems to have taken a leap in the pricing for Byooviz. In an interview last year, Peter Downs, an analyst with Market Scope, said that the first biosimilars in other therapeutic areas, such as oncology or immunology, typically come in 10 to 15 percent lower than the reference product. “But by the time you get the third one, it typically comes in at about 60 percent of the reference price,” he said. Byooviz, however, is already there, leaving payers and providers wondering where Coherus will go with its pricing if the FDA approves CHS-201.
Byooviz is approved for treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.
Getting on formularies
Ms. Scaife says Biogen has already engaged payers to put Byooviz on their formularies. “A number of large payers have actually already granted Byooviz parity access to the reference product Lucentis,” she says.
The company’s marketing team is also reaching out to commercial regional and national payers, including Medicare Advantage and traditional Medicare administrators, to educate them about biosimilars.
While Biogen has commercialized biosimilars in immunology in Europe, Byooviz represents its first foray into biosimilars in the United States. “We will definitely leverage the experience in Europe for our U.S. adoption,” she says. That includes a multifaceted provider education program centered on live meetings and monographs.
“And as biosimilars become more widely adopted in clinical practice, we will work closely with third-party investigators to generate real-world evidence on the clinical safety and effectiveness of biosimilars,” Ms. Scaife says.
Next up: Coherus
Last year, the FDA set a Biosimilar User Fee action date of August 2 on Coherus’ Biologic License Application for CHS-201. Coherus obtained the U.S. license from Bioeq. But that won’t be the last word on anti-VEGF biosimilars in the United States. Xbrane Biopharma withdrew the Biologic License Application (BLA) it filed with the FDA for its Lucentis biosimilar candidate, Xlucane, and is contemplating a timeline for resubmission.
Meanwhile, a number of biosimilars of Eylea (aflibercept, Regeneron Pharmaceuticals), which comes off patent next year, are in clinical trials. They include SB15, which Biogen is developing with Samsung Bioepis, with whom it developed Byooviz. The Phase III trial finished up in March.
On the lower end of the anti-VEGF price spectrum, Outlook Therapeutics has submitted a BLA to the FDA for Lytenava, an ophthalmic formulation of the widely used Avastin (bevacizumab, Genentech/Roche), which is used off-label to treat AMD, diabetic macular edema and branch retinal vein occlusion. Outlook says it anticipates marketing approval by early 2023.
The Food and Drug Administration has approved Beovu (brolucizumab, Novartis) 6 mg for the treatment of diabetic macular edema. The approval was based on year one data from the Phase III KESTREL and KITE studies, which met their primary endpoint of noninferiority in change in best-corrected visual acuity from baseline vs. aflibercept.
Apellis Pharmaceuticals has submitted a New Drug Application (NDA) with the FDA for intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration. Pegcetacoplan is an investigational, targeted complement factor 3 therapy. The NDA submission is based on 12- and 18-month results from the Phase III DERBY and OAKS studies, and 12-month Phase II FILLY study results.
Luxa Biotechnology, a joint venture of Y2 Solution and the Neural Stem Cell Institute, reports transplantation of the cell product RPESC-RPE-4W into the first participant with dry AMD in its Phase I/IIa clinical trial. RPESC-RPE-4W is derived from the retinal pigment epithelium stem cell in the adult human retina. The trial is being conducted at the University of Michigan Kellogg Eye Center, Ann Arbor.
AAO panel: ‘De-adopt’ endogenous Candida endophthalmitis screening
For decades hospitalists called in ophthalmologists to routinely screen for intraocular infection in patients who contracted Candida bloodstream infections. Now, an American Academy of Ophthalmology panel, after reviewing the available evidence, has issued recommendations that “this low-value practice should be de-adopted.”1
“There just hasn’t been a proven benefit to this,” Mark P. Breazzano, MD, lead author of the recommendation-writing panel, says. “In medicine we have this sort of cognitive bias or confirmation bias where we want to intervene and thus help people, as we all should, but we need to recognize when the rare chance of helping someone might be outweighed by the potential benefits of modifying treatment.” Dr. Breazzano is with Retina Vitreous Surgeons of Central New York, based in Syracuse, and is an assistant professor at SUNY Upstate Medical University.
The panel found that the practice, dating to the 1970s and confirmed as late as 2016 by the Infectious Disease Society of America (IDSA),2 simply had no medically sound justification. The AAO panel’s recommendations fall in line with similar guidance that the Royal College of Ophthalmologists and Intensive Care Society in the United Kingdom issued in 2020.3 Dr. Breazzano says the U.S. IDSA declined to participate in drafting the new AAO guidelines.
Not the case anymore
Patients with indwelling catheters are prone to Candida bloodstream infections. Dr. Breazzano says the concept of routine endophthalmitis screening in these patients dates to a time when antifungal therapies weren’t widely available and was based on conflicting clinical definitions. That’s not the case anymore.
The AAO panel evaluated a number of case series and systematic reviews—randomized clinical trials and rigorous studies of Candida endophthalmitis secondary to fungal infections aren’t available—in reaching their consensus, Dr. Breazzano says. The rate of endophthalmitis in these cases was less than 1 percent, he says. “And within that, none have actually been directly confirmed by ocular tissue,” he says. RS
—Richard Mark Kirkner
1. Breazzano MP, Bond JB, Bearelly S, et al, for the American Academy of Ophthalmology. American Academy of Ophthalmology recommendations on screening for endogenous Candida endophthalmitis. Ophthalmology 2022;129:73-76.
2. Barlam TF, Cosgrove SE, Abbo LM, et al. Implementing an antibiotic stewardship program: Guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clin Infect Dis. 2016;62:e51e77.
3. Ophthalmic Services Guidance. Eye care in the intensive care unit (ICU). April 2020. The Royal College of Ophthalmologists and Intensive Care Society. https://www.rcophth.ac.uk/wp-content/uploads/2020/04/Eye-Care-in-the-Intensive-Care-Unit-2020.pdf. Accessed June 29, 2022.