Could biosimilars become the first-line option for AMD treatment?
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Biosimilars will be pivotal in some countries
Anti-VEGF agents have transformed retinal disease management.
However, the benefit of anti-VEGF therapy is still limited by the higher cost of treatment, specifically in the areas of the world where patients are not well covered with insurance and need to pay from their pocket.
Off-label bevacizumab usage has been associated with the risk for infection due to a lack of compounding pharmacies in such areas. The entry of biosimilars to Lucentis (ranibizumab, Genentech) in India has made a significant change and improved access to anti-VEGF therapy for many patients.
Recent biosimilar approvals by the FDA and European Medicines Agency have brought this therapy to the forefront, and this new approach has the potential for saving health care spending on these drugs. However, it is yet to be seen how biosimilar anti-VEGFs would fit into the crowded space of anti-VEGFs globally.
As of now, three companies are manufacturing ranibizumab biosimilars, significantly bringing down the cost. We foresee that biosimilar ranibizumab will replace the use of off-label Avastin (bevacizumab, Genentech) in countries such as India. Biosimilar aflibercept molecules are in the pipeline and will enter the market as soon as the Eylea (aflibercept, Regeneron) patent expires. This will not only improve access to medications for many patients but also possibly improve adherence, which indirectly will affect the quality of life and productivity of these patients.
I hope that these Indian companies will match the stringent requirements of the FDA and EMA, so that their products they will be available globally. As of now, they are only available in India.
Sundaram Natarajan, MD, is with Aditya Jyot Eye Hospital, Mumbai, India.
Most US specialists have reservations
Most retina specialists, myself included, have reservations and concerns about biosimilars in general.
We have long-standing experience with the innovator biologic agents and feel comfortable using them. Undoubtedly, drug cost is a significant problem, and we are fortunate to be able to use off-label Avastin (bevacizumab, Genentech), which has been for years an effective and safe alternative to the more expensive licensed drugs. Because the approval process for biosimilars is different, much less extensive and significantly shorter, I believe that our first choice will remain on-label anti-VEGF medications or Avastin.
However, with the approval of biosimilars, I am afraid that our choice may be limited and to some extent dictated by insurance providers. Currently, with some providers, we have to go through step therapy, using Avastin at first and then switching to a licensed anti-VEGF if we can prove that patients performed suboptimally, sometimes after at least three injections. We may have to go through a similar step approach with one or possibly multiple biosimilars before we can switch.
I work in a large academic institution, with the ability to have many medications in our formulary, but I have concerns about smaller hospitals and private practices with limited storage space if we are forced to go through a certain number of biosimilars in our treatment pathway.
On the other hand, if a biosimilar to Avastin were approved, I think that this could be a game changer for us as clinicians and for the market because there would be for the first time an on-label bevacizumab we could use.
Katherine Talcott, MD, is with Cole Eye Institute at Cleveland Clinic.
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