BLOG: Meaningful data needed to show biosimilar equivalence
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The use of bevacizumab has allowed patients to receive adequate care for various retinal diseases including wet age-related macular degeneration, diabetic retinopathy, diabetic macular edema and macular edema due to retinal vein occlusions.
Additionally, now there is level one evidence that shows equivalence in various disease states, for example, in those with DME and 20/40 or better visual acuity, while maintaining a separate place, again based upon evidence, for more expensive biologics that show superiority in some clinical situations.
Biosimilars offer the opportunity to use bevacizumab in a fashion that is finally regulated and attempts to standardize the medication, as we have previous data showing great variability in compounding pharmacies to provide the drug. Insurance companies are focused on the cost of care and clinical outcomes, and unfortunately, the cost of care is significant with these disease states. Therefore, while compounded bevacizumab might not be with us in the future due to the concerns around safety, biosimilars might be the next best alternative.
There is, however, a concerning feature from many biosimilar studies, and that is in regard to study design. The most recent data from Outlook Therapeutics on its biosimilar appears to paint a rosy picture of superiority of bevacizumab to ranibizumab for neovascular AMD. However, the treatment arms are completely different between the drugs and, in fact, bias the results toward bevacizumab based upon the criteria for treatment in the ranibizumab arm. Therefore, I would encourage those in practice, industry and insurance to review the clinical trial designs to determine if they are ethical and sound and provide meaningful information to show that these treatments are truly equivalent rather than putting forward studies in which there are clearly shortcomings.
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