Regulatory opportunities for treating age-related macular degeneration with bevacizumab biosimilars in low-middle income countries.
Zee, Ivar van der
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Neovascular age-related macular degeneration (nAMD) is a progressive eye-disease that can be treated through off-label intravitreal administration of bevacizumab, an anti-VEGF antibody registered for oncologic indications. Despite its inclusion in the WHO essential medicines list, bevacizumab remains mostly inaccessible to nAMD patients in low- and middle-income countries (LMICs), partly due to regulatory hurdles preventing bevacizumab from being registered in LMICs. This paper assesses whether LMIC-oriented regulatory pathways like EU-M4all are effective tools for overcoming these hurdles and improving patient access to bevacizumab or bevacizumab biosimilars in LMICs. We found that while multiple LMIC-oriented regulatory pathways are available, they are generally aimed at addressing acute public health issues in the short-term. As a result, bevacizumab would likely not meet the eligibility criteria for most of them due to either its limited perceived urgency, pathways being solely aimed at specific therapeutic areas (e.g., HIV), or pathways not allowing biological products. This is unfortunate since nAMD poses an ever-increasing disease- and economic burden to LMICs. Therefore, we suggest stringent national regulatory authorities to either extend the scope of their existing pathways, or design novel ones aimed gradually worsening, non-acute, disease burdens like the one nAMD causes.