The price of the biosimilar may also be persuasive for patients.
July 2022 is a big month in ophthalmology because it marks the arrival of the first biosimilar specifically indicated for ocular disease, Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab). Byooviz is an antivascular endothelial growth factor (VEGF) drug that is FDA approved for wet age-related macular degeneration, macular edema, and myopic choroidal neovascularization.
Previously, only biosimilars of Avastin (bevacizumab) were available for ocular treatment and and only for off-label prescription. These do not have the endorsement of the American Academy of Ophthalmology (AAO).
In June, Spherix Global Advisors reported survey data suggesting ophthalmologists are about evenly divided on whether they will give Byooviz a trial with their patients within the first three months of launch.
But the lower cost of Byooviz relative Lucentis is an incentive to make the switch. The cost of a single-use vial of Byooviz is 9% lower than the average for Lucentis: $1,130 vs $1,242, respectively. Both products require six to 12 injections per year.
Unlike with Avastin biosimilars, there is specific clinical evidence that supports the use of Byooviz for ophthalmology purposes, notes Jillian Scaife, senior director of Market Access for Biogen. “This was approved by the FDA based on our comprehensive data package, including data from a phase 3 clinical trial,” Scaife says.
Biogen is the US marketing partner of Samsung Bioepis, a South Korean company, which developed Byooviz.
To overcome hesitation ophthalmologists may have, Biogen is planning an educational blitz. This will include e-learning platforms and symposia at global conferences, along with real-world study of Byooviz outcomes.
What may make Biogen’s job easier is that the AAO views the Byooviz savings proposition favorably, says George Williams, M.D., senior secretary for advocacy and a past president of the AAO. “Already, we have seen step therapy protocols incorporate Byooviz as a requirement before allowing Lucentis or other branded anti-VEGF drugs. This will be important as Medicare Advantage continues to grow, since 98% of Medicare Advantage plans now require step therapy for Part B drugs. I expect that most step therapy protocols will require a trial with Byooviz.”
Some doctors will not want to switch their patients to Byooviz if they are doing well on Lucentis, regardless of savings, and payer preferences also will play a role in acceptance, as will “the logistics of obtaining, carrying, and billing for Byooviz,” notes Williams.
Scaife said Biogen’s efforts to support uptake will include ready answers to ophthalmologists’ questions about reimbursement.
The field of monoclonal antibodies for macular degeneration has grown more diverse with recent entries such as Vabysmo (faricimab) and Susvimo (ranibizumab), which is delivered via implant of a long-lasting medicine reservoir. These drugs are part of a move away from multiple intravitreal injections each year to an experience that is more tolerable for patients. On a patient-by-patient basis, Vabysmo may require fewer injections than Lucentis or Byooviz.
Eylea (aflibercept) is the biggest seller ($5.8 billion, 2021) in the anti-VEGF group and will face biosimilar competition when it reaches the end of its patent exclusivity lifetime. Estimates from various medical media sources suggest key US patents will expire from 2023 to 2028.
Samsung Bioepis and Biogen are partners in the development and commercialization of SB15, an Eylea biosimilar that is now being evaluated in a phase 3 clinical study in patients with wet age-related macular degeneration.
In the United States, Byooviz is aimed at a Lucentis market of $1.46 billion. Samsung Bioepis and Biogen also have approvals for this product in the European Union, Great Britain, and Canada, although launch dates have not been disclosed. The Lucentis market outside the United States is $2.16 billion.