First FDA-approved ophthalmic biosimilar ranibizumab-nuna launches in the United States & More News Here

Ranibizumab-nuna (Byooviz, Biogen), a biosimilar referencing ranibizumab (Lucentis, Genentech) launched in the United States in the present day, as introduced by Biogen Inc. and Samsung Bioepis Co., Ltd. It will likely be commercially accessible on July 1, 2022, through main distributors throughout the US, however promotional exercise, healthcare supplier engagement, and affected person advocacy group collaborations have already begun.

According to the firms, ranibizumab-nuna will likely be commercially accessible via main distributors throughout the United States, with an inventory worth of $1,130 per single use vial to manage a 0.5mg through intravitreal injection.

Approved in September of 2021, ranibizumab-nuna is the first FDA-approved ophthalmic biosimilar. The biosimilar is authorized for the remedy of neovascular age-related macular degeneration (AMD), macular edema following retina vein occlusion (RVO) and myopic choroidal neovascularization.

“The launch of BYOOVIZ, the first ophthalmology biosimilar in the U.S. marks a key step towards increasing options and reducing the financial burden associated with current anti-VEGF treatments,” Christopher Hansung Ko, President and Chief Executive Officer at Samsung Bioepis, mentioned in a press launch. “The priority of Samsung Bioepis is ensuring patients’ access to the medicines they need, and we will continue to advance our pipeline to bring better access to biologic treatments, by leveraging our decade of experience in developing, manufacturing, and commercializing these important biologics.”

The FDA primarily based its approval of ranibizumab-nuna on the part 3 outcomes of the AMD examine (NCT03150589) in which SB11 was evaluated for treating nAMD.

In the randomly assigned, double-masked, parallel group, multicenter trial, 705 sufferers had been enrolled; 634 sufferers accomplished the examine out to week 52. The biosimilar product was in contrast with reference ranibizumab.

Biosimilars are merchandise which have comparable efficacy and security profiles to the unique. A significant distinction between the unique ranibizumab and the biosimilar is that the latter is significantly inexpensive.

While neovascular (moist) AMD is much less frequent than dry AMD, it’s chargeable for the majority of the extreme imaginative and prescient loss related to AMD.¹ Wet AMD has been historically handled with anti-VEGF remedy, however excessive prices usually problem optimum scientific outcomes.² Biosimilars could alleviate a few of the monetary burden related to present anti-VEGF therapies.

Ian Henshaw, senior vice chairman and world head of Biosimilars at Biogen, famous in a press launch that the launch of ranibizumab-nuna in the United States is “an important moment for patients, healthcare providers, payers, and the entire healthcare system.”

“Patients suffering from retinal vascular disorders now have a more affordable treatment option,” Henshaw mentioned in an announcement. “Our research with physicians shows cost is cited as a leading barrier to patients initiating treatment, with one third of patients unable to afford medication.”

Henshaw additionally famous that ranibizumab-nuna has the potential to develop entry to sufferers affected by retinal problems that may consequence in everlasting imaginative and prescient loss, whereas additionally saving the U.S. healthcare system billions of {dollars}.

According to the firms, ranibizumab-nuna is the first biosimilar launch in the U.S. beneath the Biogen and Samsung Bioepis partnership.

In addition to the U.S., ranibizumab-nuna was additionally authorized as the first ophthalmology biosimilar in Europe (2021), the United Kingdom (2021), and Canada (2022).

The firms additionally famous that the Biogen and Samsung Bioepis commercialization settlement consists of two ophthalmology biosimilar candidates, ranibizumab-nuna and SB15, a biosimilar candidate referencing aflibercept (Eylea, Regeneron Pharmaceuticals). Samsung Bioepis is chargeable for improvement, regulatory registration, and manufacture of the merchandise, whereas Biogen is chargeable for commercialization.

The place of biosimilars

In commenting on the relevance of the product’s approval to the ophthalmic group, Se Joon Woo, MD, PhD, a professor in the Department of Ophthalmology and director of the Medical Device Research and Development Center at Seoul National University College of Medicine and Seoul National University Bundang Hospital in South Korea, defined that the FDA approval for the first ophthalmic biosimilar has important significance as a result of ophthalmologists are new to biosimilars.

Ophthalmologists trust in FDA-approved merchandise, and the undeniable fact that it’s FDA-approved provides us confidence that the remedy can be utilized safely and successfully in sufferers with ophthalmic circumstances, simply the identical as reference ranibizumab.

Moreover, there are numerous anti–vascular endothelial development issue therapies and different biologic brokers which are used to deal with ophthalmic circumstances, and I feel there’s a rising anticipation for the subsequent ophthalmology biosimilars together with biosimilars for aflibercept which are at the moment in improvement and will likely be launched in the coming years.

References

1. American Academy of Ophthalmology. Age-Related Macular Degeneration Preferred Practice Pattern Available at: https://www.aaojournal.org/article/S0161-6420(19)32091-3/fulltext. Accessed June 2022.

2. Wykoff et al. Optimizing Anti-VEGF Treatment Outcomes for Patients with Neovascular Age-Related Macular Degeneration. J Manag Care Spec Pharm, 2018 Feb;24(2-a Suppl):S3-S15. https://doi.org/10.18553/jmcp.2018.24.2-a.