Adoption of ophthalmic biosimilars expected to remain slow
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Most of us are familiar with the different classes of eye drops.
Eye drops are typically initially released in a branded patented version by a single company. Eye care’s prior three most successful branded patented eye drops, which all reached $1 billion or more in annual sales, were Timoptic (timolol maleate ophthalmic solution) from Merck and Co., Xalatan (latanoprost ophthalmic solution) from Pfizer, now Viatris, and Restasis (cyclosporine ophthalmic emulsion 0.05%) from Allergan, now AbbVie. While on patent, these eye drops first sold for $300 to $500 per bottle. Once a new drug’s patents expire, another manufacturer can commercialize a generic version if it contains the exact same concentration of active pharmaceutical ingredient (API). For an eye drop, the vehicle, preservative, and bottle type and size can be different, but the API has to have the exact same chemical structure, potency and concentration.
Today, according to GoodRx, generic timolol sells for as low as $2, generic latanoprost in the $8 to $10 range and generic cyclosporine eye drops for about $100 per bottle. The transition from branded patented to non-branded generic eye drops in these three cases resulted in a significant 80% to 99% reduction in price per bottle.
Biologics are different. In ophthalmology, our billion dollar-plus annual revenue branded patented biologics are represented by the injectable monoclonal antibody anti-VEGF drugs Lucentis (ranibizumab, Genentech) and Eylea (aflibercept, Regeneron). Unlike an eye drop’s API, which is a reproducible specific chemical entity molecule, biologics cannot be exactly copied. For this reason, the category of biosimilars was created by our regulatory agencies, including the FDA and the European Medicines Agency.
In the United States, to become FDA approved for commercialization, a biosimilar has to prove in clinical trials that it has the same active properties and generates a similar clinical outcome as an FDA-approved biologic. This is a far more expensive and time-consuming process than that required of a generic eye drop manufacturer. For this reason, while biosimilars are usually slightly less expensive than their branded patented predecessors, the savings are much less than for a generic eye drop.
The first ranibizumab biosimilar was approved in 2021, with a second approved in 2022. In similar fashion, three biosimilars for aflibercept were approved earlier this year.
As described in the accompanying Healio | OSN cover story, commercial adoption of biosimilar anti-VEGF drugs by retina specialists in the U.S. has been slow. Barriers to biosimilar adoption include patent litigation, smaller incremental cost savings and especially the reticence of those who perform intravitreal injections for sight-threatening retinal diseases to trust the efficacy of a biosimilar when they have years of positive clinical experience with the established branded patented alternatives.
The transition from branded patented eye drops to their generic alternatives occurred rapidly and was catalyzed by payers and pharmacists who could legally substitute a cheaper generic version of eye drop even when an eye care professional prescribed the branded patented alternative. In the case of biologics, to date the physician remains in control of which biologic is to be injected into the eye, and those ophthalmologists who treat sight-threatening retinal diseases have been reluctant to adopt the newer biosimilar anti-VEGF drugs. Unless mandated as step therapy by the payers, I believe biosimilar adoption for anti-VEGF intravitreal injection therapy will continue to be slow until it proves itself in broad clinical use.
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