BLOG: Biosimilar or biosameoldsameold?
In 2021, Byooviz was approved as a biosimilar drug to Lucentis, offering a potentially lower-cost alternative to this highly popular, branded treatment for neovascular age-related macular degeneration and macular edema.
While we should always be excited about a new entry to the market, this drug is likely to face some headwinds to adoption, fairly or unfairly.
As our cover story in this issue of Healio/Ocular Surgery News illustrates, biosimilar drugs are like a generic equivalent for a drug that is considered a biologic, ie, a man-made protein designed to regulate biologic processes, such as suppressing the vascular endothelial growth factor receptor. Byooviz (ranibizumab-nuna, Biogen/Samsung Bioepis) has been demonstrated to have similar clinical properties to Lucentis (ranibizumab, Genentech). But will clinicians choose it instead of their traditional choices?
The first consideration is cost. Byooviz will list for $1,130 per dose, according to the Biogen website. That’s about $800 less than the cost of Lucentis and about $1,100 more than the cost of Avastin (bevacizumab, Genentech), which is used off label but is still the most used anti-VEGF drug in the U.S.
Any patient switching to Byooviz will be either “upgrading” from Avastin or “downgrading” from Lucentis. Most patients currently receiving Avastin do so because they do not have coverage for a branded, on-label medication and choose not to pay thousands of dollars out of pocket each year for their anti-VEGF treatment. For patients doing well on Avastin (and most are), what market force would prompt them to switch to a more expensive drug?
“Downgrading” from Lucentis might be an option for some who pay a significant co-pay, and managed care organizations will probably favor the biosimilar product to save money. However, most patients taking Lucentis, comfortably covered by insurance, will resist changing to a less proven alternative. Who wants Big K cola when you can have “the Real Thing”?
Is it even fair to say Byooviz is a downgrade from Lucentis? Probably not, but in the short term, this less proven drug has to overcome resistance from clinicians that is based on very real history. Beovu (brolucizumab, Novartis), a new anti-VEGF compound, was approved in 2019 with much fanfare in the U.S. but has fallen out of favor because of post-injection vasculitis in about 3% of patients. In India, Razumab (Intas Pharmaceuticals), another Lucentis biosimilar, caused a 10% rate of sterile endophthalmitis with the first formulation that was released. To some extent, all new drugs pay for the sins of their predecessors. Many U.S. retina specialists will wait for more data before committing the fragile eyes of their patients to a new drug.
Unquestionably, drugs like Byooviz will have an important place in the future care of our patients with maculopathy. The number of biosimilar products in late clinical trials suggests that investors and drug makers are similarly optimistic. Meanwhile, clinicians know that “the enemy of truth is short-term follow-up,” and evidence that accumulates over time will help overcome both the cost and the clinical barriers to the adoption of these promising new drugs.
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