Samsung Bioepis and Biogen Announce Launch of First Ranibizumab Biosimilar in US

Approved in September 2021, partners Samsung Bioepis and Biogen have disclosed that their ranibizumab biosimilar Byooviz™ will be commercially available on July 1.

The agent is approved by the U.S. Food and Drug Administration (FDA) to treat neovascular (wet) age-related macular degeneration, macula edema following retinal vein occlusion, and myopic choroidal neovascularization.

Lower Biosimilar Cost and Expanded Ranibizumab Access

Pricing for the new biosimilar will be set at a 40% discount (or $1,130 per single use 0.5-mg vial) to the wholesale acquisition cost of the reference agent Lucentis®. According to the latest data from the federal government, the average sales price paid by Medicare for Lucentis (after discounts and rebates) is $1,409.40 (Byooviz is priced about 25% below this figure).

“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,” stated Ian Henshaw, Biogen’s Senior Vice President and Global Head of Biosimilars, in a press release. “Byooviz has the potential to expand access to patients suffering from retinal disorders that can result in permanent vision loss, while also saving the U.S. healthcare system billions of dollars.”

Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis, added, “The launch of Byooviz, the first ophthalmology biosimilar in the United States, marks a key step towards increasing options and reducing the financial burden associated with current anti-VEGF treatments.”

Mourad Farouk Rezk, MD

BR&R asked Biogen if the company believed its approach in bringing the first biosimilar to ophthalmology practice might entail considerations not seen with the other specialties now prescribing biosimilars. Mourad Farouk Rezk, MD, Head of Global Medical and Development Biosimilars at Biogen, responded via E-mail: “The use of biosimilars in ophthalmology represents an exciting new chapter for patients, healthcare providers, and the healthcare system as a whole. While the treatment with anti-VEGFs is well established, this first biosimilar option in ophthalmology in the United States necessitates a profound understanding of safety and efficacy. This relates to the well-regulated and extensive pre-clinical and clinical evidence of biosimilarity.” 

He continued, “Byooviz’s rigorous and high-quality development, the robust evidence of clinical comparability to the reference biologic and Biogen’s commitment to partner with healthcare providers and address their scientific questions through education and real-world evidence generation will enable Byooviz’s long-term success in ophthalmology.”

A Complicated Biosimilar Market

As previously reported, the ophthalmology biosimilar market may be very interesting, featuring several competing alternatives. Two other biosimilar manufacturers may receive FDA approval for their own versions of ranibizumab this year. Reference product Eylea® is the most prescribed branded biologic for these indications, and several aflibercept biosimilars may be approved in 2023 or 2024. Bevacizumab that is compounded by a pharmacy for vitreal injection is a very frequently used, very low-cost alternative. Roche introduced a ranibizumab port-injection system in 2021, which reduces the frequency of injections needed.

Outlook Therapeutics is also attempting to bring a manufactured form of bevacizumab to market. However, Outlook was handed a setback by the FDA on May 31, deciding against approval of the company’s biologic licensing application for ONS-5010 and requesting additional information. Outlook Therapeutics indicated that it will resubmit its application for ONS-5010 by September 2022.

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