FDA Designates Ranibizumab-nuna (Byooviz) as Interchangeable to Lucentis

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Samsung Bioepis gains FDA interchangeability designation for its ranibizumab (Lucentis) biosimilar, ranibizumab-nuna (Byooviz), in the treatment of wAMD, macular edema following RVO, and mCMV

US FDA logo in black over a white background. | Credit: US Food and Drug Administration

Credit: US Food and Drug Administration

Samsung Bioepis announced the US Food and Drug Administration has granted an interchangeability designation for their ranibizumab (Lucentis) biosimilar, ranibizumab-nuna (Byooviz).

The first ophthalmology biosimilar to receive approval from the FDA in September 2021, the latest designation as a biosimilar product interchangeable with Lucentis indicates the agent as interchangeable across previous indications, including treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).1

Approved by the FDA in a letter dated October 03, 2023, the approval is based on a supplemental biologics license application (BLA) from July 2022, which was amended in June 2023 based on a provisional determination letter issued by the agency in May 2023.1

The initial FDA approval for ranibizumab (Lucentis) dates back to 2006, when the agent received approval for the treatment of wet AMD based on data from the pivotal MARINA and ANCHOR trials. Since the first approval, the agent has gone on to receive approval for multiple other forms of ophthalmic disease.2

Ranibizimub-nuna (Byooviz) became the first biosimilar agent to receive approval for an ophthalmic indication in September 2021 when it received approval for wet AMD, macular edema following RVO, and mCMV. Through an agreement between Samsung Bioepis and Biogen, commercialization of the ranibizumab biosimilar began in June 2022. At the time of launch, the list price for a single 0.5 mg dose of ranibizumab-nuna was $1,130, which was 40% lower than the current list price of the reference product.3

"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," said Christopher Hansung Ko, president and chief executive officer at Samsung Bioepis, at the time of launch in June 2022. “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.”

According to the October 2023 letter from the FDA provided by Samsung Bioepis, the agency has included a pair of postmarketing reporting commitments the company will be required to complete. These were providing a bioburden test method suitability data for in-process samples from at least one additional lot of SB11 drug substance and to Perform real-time drug product commercial container closure system leachate studies using appropriate test methods to identify and quantify volatile organic compounds (VOC), semi-VOC, non-VOC, and trace metals at regular intervals through the end of shelf life. As part of the latter requirement, the company will be required to update results annually in the BLA Annual Report. The timetable submitted by Samsung Bioepis in July 2021 indicates the final report from these studies will be submitted no later than December 31, 2024.1

References:

  1. SUPPLEMENT APPROVAL . US Food and Drug Administration. Published online October 2023. Accessed October 24, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761202Orig1s006ltr.pdf.
  2. Genentech Inc. Genentech, Inc.. release: FDA approves Lucentis for the treatment of wet age-related macular degeneration. BioSpace. June 30, 2006. Accessed October 24, 2023. https://www.biospace.com/article/releases/genentech-inc-release-fda-approves-lucentis-for-the-treatment-of-wet-age-related-macular-degeneration-/.
  3. Biogen. Biogen and Samsung Bioepis’ BYOOVIZTM (ranibizumab-nuna) launches in the United States. Biogen. June 2, 2022. Accessed October 24, 2023. https://investors.biogen.com/news-releases/news-release-details/biogen-and-samsung-bioepis-byooviztm-ranibizumab-nuna-launches.
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