The documents include specific ones for hemophilia, retinal disorders, and rare diseases, as well as manufacturing, testing, and patient follow-up.
Intravitreal injection with anti–vascular endothelial growth factor (anti-VEGF) drugs has represented a major step forward for patients with retinal diseases, and the upcoming biosimilars market for these drugs—including aflibercept and ranibizumab, as well as off-label bevacizumab—is beginning to take shape. However, there have been some lingering concerns about the safety of these drugs, as increased mortality has been reported after anti-VEGF treatment in the general population.
The pan-Canadian Pharmaceutical Alliance engaged the Canadian Agency for Drugs and Technologies in Health to lead a multiphase stakeholder consultation process to encourage biosimilar uptake.
Given the availability of biosimilars of infliximab, etanercept, and adalimumab in multiple markets worldwide, and given the cost savings associated with the biosimilars, there is growing interest in switching patients receiving maintenance treatment for uveitis to these biosimilar options, but data in switching patients with uveitis have been limited.
The field of biosimilar contenders for anti–vascular endothelial growth factor (anti-VEGF) therapies is taking shape, with biosimilar developer Coherus seeking to launch its ranibizumab biosimilar in 2021 and Samsung Bioepis having reached a commercialization agreement for 2 biosimilar anti-VEGFs of its own. Last week, a study published in JAMA Ophthalmology supported the use of anti-VEGF agents in wet age-related macular degeneration (AMD), saying that, though these drugs are costly, they may provide substantial economic value to both patients and society.
Researchers report that there were no differences in visual acuity letter score (VALS) and central subfield thickness (CST) outcomes at month 24 between patients treated with bevacizumab and those treated with aflibercept in the SCORE2 study.
Samsung Bioepis announced Wednesday that it has entered into a new commercialization agreement with partner Biogen for 2 ophthalmology biosimilars that are currently in development.
Even as biosimilars of anti–vascular endothelial growth factor (anti-VEGF) agents are coming to market and advancing through the pipeline, a new agent that may have substantial benefits for patients with wet age-related macular degeneration (AMD) has been approved by the FDA: brolucizumab, which sponsor Novartis will sell as Beovu.
Vial sharing for bevacizumab that would otherwise have been discarded yielded a 97.88% reduction in the total cost of a single year of intravitreal injections, as well as a 96.54% increase in the number of injections performed.
Treating macular edema associated with central retinal vein occlusion (CRVO) with aflibercept was noninferior to ranibizumab treatment at 100 weeks, while the results for bevacizumab versus ranibizumab were inconclusive.

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