January 10, 2023
Implications of Biosimilar Availability in the United States’ Ophthalmology Markets Highlighted in New Spherix Global Insights Study
80 US ophthalmologists provided feedback on their use and perceptions of biosimilar agents and their impact on the total treatment landscape
EXTON, Pa., January 10, 2023 – Ophthalmologists saw the entry of the first biosimilars into the armamentarium in 2022 with the launch of Biogen and Samsung’s Byooviz and Coherus Bioscience’s Cimerli (both biosimilars to Genentech’s Lucentis). But are they being used?
Spherix’s Special Topix™: Biosimilars Today and Tomorrow (US) service includes access to ongoing feedback from US ophthalmologists to gauge their current understanding of the biosimilar landscape, their perceptions of biosimilars, their current and projected uptake of the agents (focused on biosimilars of Genentech’s Lucentis), as well as their perspectives on pipeline (focused on biosimilars of Regeneron’s Eylea).
According to the December 2022 Spherix report, while access has opened to biosimilars in ophthalmology since last wave (fielded November 2021) comfort and familiarity ratings with the class has gone down. Ophthalmologists are learning more about biosimilars though journal articles, CME activities, conferences presentations, and colleagues, yet this increased knowledge has not yet translated to increased comfort with the agents. Concepts unique to the FDA biosimilar approval pathway such as extrapolation of indication approvals and interchangeability have complicated the matter with research indicating ophthalmologists are less comfortable with both as compared to the previous year and extreme comfort with the level of safety and efficacy data needed for a biosimilar to gain FDA approval has also decreased from last wave.
The launches of Byooviz and Cimerli have not made a large splash with aided awareness of the agents’ availability according to almost half of the ophthalmologists surveyed. User base and share for both agents is currently low and projections of increase are modest. Drivers for use of available biosimilars include cost and access considerations while barriers center more on concerns regarding comparable safety and efficacy with reference biologics.
The low-key launch executed for both Byooviz and Cimerli has not helped the cause with the majority of surveyed ophthalmologists never having had a face-to-face visit with sales representatives from either agent.
With the prospect of an aflibercept biosimilar (a biosimilar to Regeneron’s Eylea) and the potential for a High Dose version of Eylea, the retina landscape is certain to continue to evolve. While the appeal of an aflibercept biosimilar appears greater than the currently available ranibizumab biosimilars (biosimilars of Lucentis), awareness and familiarity of the aflibercept biosimilar pipeline are extremely low and intent to use appears predicated on other branded options available at the time and pressure from third parties such as payers and health institutions.
Most ophthalmologists are unaware Viatris (a Mylan company) has filed an aflibercept biosimilar for review with the FDA and even fewer report any familiarity with M710, the filed agent. Ophthalmologists are not very likely to prescribe an aflibercept biosimilar over Eylea and even less likely to prescribe it in the future over high dose Eylea when and if that becomes available. There is minimal familiarity with the pipeline biosimilar manufacturers Biogen, Bausch, Amgen, Samsung, Sandoz, Coherus Biosciences, Lupin, Alvotech, Celltrion, Xbrane, and Formycon. However, ophthalmologists do have concerns over manufacturing conditions when it comes to biosimilars and most will be at least somewhat influenced by the manufacturer regarding prospective use of the agents.
Though ophthalmologists have now had access to an FDA approved biosimilar for half a year, the future of biosimilars in ophthalmology remains uncertain. Continued education and financial incentives will become essential if biosimilars are to become a mainstay in ophthalmological markets.
Special Topix™ is an independent service that includes access to a report or series of reports based on current events or topics of interest in specialty markets covered by Spherix.
About Spherix Global Insights
Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry. The company’s unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers.
A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology and ophthalmology.
Spherix Global Insights Contacts:
Chrystal Ferguson, Insights Director, Ophthalmology
Scott Upham, Corporate Communications