The price can also be convincing. The price of the biosimilar is expected to be around 9% lower than that of its reference product, Lucentis.
July 2022 is a big month in ophthalmology as it marks the arrival of the first biosimilar specifically indicated for eye diseases, Byooviz (ranibizumab-nuna), a biosimilar of Lucentis (ranibizumab). Byooviz is an FDA-cleared anti-vascular endothelial growth factor (VEGF) drug for wet age-related macular degeneration, macular edema, and myopic choroidal neovascularization.
Previously, only Avastin biosimilars (bevacizumab) were available for ocular treatment and only for off-label prescription. These are not endorsed by the American Academy of Ophthalmology (AAO).
In June, Spherix Global Advisors reported survey data suggesting that ophthalmologists are about evenly split on whether they will give Byooviz a try with their patients within the first three months of launch.
But the lower cost of Byooviz compared to Lucentis is an incentive to make the switch. The cost of a single-use vial of Byooviz is 9% lower than the Lucentis average: $1,130 versus $1,242, respectively. Both products require six to 12 injections per year.
Unlike Avastin’s biosimilars, there is specific clinical evidence that supports the use of Byooviz for ophthalmic purposes, notes Jillian Scaife, senior director of market access for Biogen. “This has been cleared by the FDA based on our full data set, including data from a Phase 3 clinical trial,” Scaife said. Managed Healthcare Executive®.
Biogen is the US marketing partner of Samsung Bioepis, a South Korean company, which developed Byooviz.
To overcome the hesitations that ophthalmologists may have, Biogen is planning an educational blitz. This will include online learning platforms and symposia at global conferences, as well as real-world study of Byooviz results.
What can make Biogen’s job easier is that the AAO looks favorably on Byooviz’s savings proposal, says George Williams, MD, principal secretary for advocacy and former president of the AAO. “We have already 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, as 98% of Medicare Advantage plans now require a step therapy for part B drugs. I expect most step therapy protocols will require a trial with Byooviz.
Some physicians will not want to switch their patients to Byooviz if they do well with Lucentis, regardless of the savings, and payer preferences will also play a role in acceptance, as will “the logistics of obtaining, transporting and invoicing of Byooviz”. notes Williams.
Scaife said Biogen’s efforts to support adoption will include ready answers to questions from ophthalmologists about reimbursement.
The field of monoclonal antibodies for macular degeneration has diversified with recent entries such as Vabysmo (faricimab) and Susvimo (ranibizumab), which is delivered via the implantation of a long-lasting drug reservoir. These drugs are part of a move away from multiple intravitreal injections each year toward a more tolerable experience for patients. Patient by patient, Vabysmo may require fewer injections than Lucentis or Byooviz.
Eylea (aflibercept) is the anti-VEGF group’s biggest seller ($5.8 billion, 2021) and will face competition from biosimilars when it reaches the end of its patent exclusivity term. Estimates from various medical media sources suggest that major 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 currently being evaluated in a Phase 3 clinical study in patients with wet age-related macular degeneration.
In the United States, Byooviz is targeting a Lucentis market of $1.46 billion. Samsung Bioepis and Biogen also have approvals for this product in the European Union, Britain and Canada, although launch dates were not disclosed. The Lucentis market outside the United States is $2.16 billion.