Speakers during a LinkedIn Live panel discussion expressed a dire need for all stakeholders to work together to increase education efforts, provide clarity on safety and interchangeability, and encourage adoption of biosimilars in ophthalmology.
A panel of experts in the ophthalmology and biosimilars fields expressed the need for more collaboration between stakeholders in these spaces to encourage the use of ophthalmology biosimilars.
“We do believe that this endeavor is beyond the acts of a single company. It's going to take an industry; it's going to take advocacy groups. It's going to take all of us to make a change in today's adoption of biosimilars in the US healthcare space,” said Tom Newcomer, vice president and head of market access at Samsung Bioepis, who provided an introduction and background during the event.
The panel discussion entitled “In Sight: The Future of Biosimilars in Ophthalmology Care” was held as a live digital forum on LinkedIn and was sponsored by Samsung Bioepis. The discussion was moderated by Alex Brill, senior fellow at the American Enterprise Institute, and was held on October 21, 2022.
The event comes after the first 2 ophthalmology biosimilars, Samsung Bioepis’ Byooviz (ranibizumab-runa) and Coherus Biosciences’ Cimerli (ranibizumab-eqrn), entered the market in June 2022 and October 2022, respectively.
Confusion on Cimerli and Interchangeability
The event began with Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars, who discussed the process behind how Cimerli obtained an interchangeability designation from the FDA, despite the product only being offered under the medical benefit, which has caused significant confusion across the ophthalmology space.
Yim explained that decision was based on 2 factors: the company’s request for the product to be reviewed for interchangeability and the route of administration. Based on the specific immunogenicity risks associated with ranibizumab injection, the FDA concluded that direct intraretinal administration by a health care provider was safe enough that Coherus did not need to submit switching study data, which is typically required for the FDA to grant interchangeability to a biosimilar.
Seenu Hariprasad, MD, interim chair and professor of ophthalmology and visual science at the University of Chicago Medicine, shared that his ophthalmologist colleagues are calling for clarity on interchangeability for retinal medications.
“The question that remains is that these are buy-and-build drugs that we use in our office. We don't go to CVS [or] Walgreens to obtain these drugs. They're administered in our office. So, how is interchangeability…relevant?.... Why even have this discussion in a retina practice when [interchangeability] is really meant to empower a pharmacist to make choices based on cost or whatever the issues are at the pharmacy level?”
More Education and Working Together
Earlier this year, a report from Cardinal Health revealed that only 40% of ophthalmologists are “very familiar” with biosimilars compared with over 90% of oncologists, rheumatologists, and diabetes care specialists. Also, compared with other specialists, ophthalmologists were less likely to say that they would prescribe a biosimilar.
Brian Lehman, MBA, MHA, RPh, director of patient advocacy and strategic alliances at Sandoz and alliance committee cochair at the Biosimilars Forum, explained that better education efforts directed at ophthalmology providers could help ophthalmologists feel more comfortable with ophthalmology biosimilars.
“There might be some providers out there who might be reluctant to search for educational research resources on biosimilars. So, there's a need to be proactive in terms of trying to get to providers and offer them different modalities with regards to education so they can get information that they need in their practices…. I would say it takes a village it's going to take multiple stakeholders with regards to getting that education out to the many individuals who are impacted by biosimilars,” said Lehman.
Hariprasad added that investment in education on biosimilars within ophthalmology fellowship programs is also important, especially as students can be impressionable and would likely be more open to using biosimilars. “These kids are going to be going out in the real world in just a few years…. Please, don’t forget about these young individuals in your educational programs,” he pleaded.
Tim Kane, senior vice president of rebate, trade relations, and formulary strategy at Magellan Health, expressed hope that ophthalmologists will come around as more payers feel comfortable enough to add ophthalmology biosimilars to formularies.
“On the medical side, in particular, policy management drives a lot of what happens within the overall drug category…. I think what we're seeing is the introduction of biosimilar after biosimilar in different categories is accelerating the plans acceptance of moving from an innovator to a to a biosimilar,” explained Kane.
Yim added that while she understands why ophthalmologists want to see more clinical data on biosimilars, there is a growing movement to get the FDA to stop requiring clinical data for biosimilar approval because data have shown that they may not be helpful in evaluating the safety and efficacy of these products. Yim expressed hope that eventually, ophthalmologists will join these efforts.
“I'm hopeful that we can get past that. Biosimilars have been around for long enough now that I think we can be a little bit more efficient, and we are coordinating with other countries to try and make that more feasible.”