The FDA has approved Samsung Bioepis’ biologic license application (BLA) for Byooviz (ranibizumab-nuna) injection 0.5 mg (10 mg/mL) as a biosimilar product that is interchangeable with Lucentis (ranibizumab) 0.5 mg (10 mg/mL) for intravitreal injection indicated to treat various retinal diseases (more on that in a moment).
Refresh me on the company.
Launched in 2012, Samsung Bioepis is a biopharmaceutical company focused on developing and delivering a pipeline of biosimilar candidates in therapeutic areas such as ophthalmology, immunology, oncology, hematology, endocrinology, and gastroenterology.
Now Byooviz.
Developed as SB11, Byooviz is a vascular endothelial growth factor (VEGF) inhibitor initially approved by the FDA in 2021 for intravitreal treatment for the following retinal diseases:
- Wet age-related macular degeneration (AMD)
- Macular edema following retinal vein occlusion (RVO)
- Myopic choroidal neovascularization (mCNV)
To note, the drug has been commercialized by Biogen since June 2022 following a 2019 exclusive commercialization agreement between Samsung Bioepis and Biogen for Byooviz and SB15 (aflibercept) in the global market.
What are the recommended dosages?
Per the prescribing info, a single-dose glass vial is designed to provide 0.05 mL via intravitreal injection (10 mg/mL solution) in the following 0.5 mg dosing schedules:
- Wet AMD
- Once a month (approximately 28 days)
- Alternative, but may not be as effective: three monthly doses followed by less frequent dosing
- Alternative, but may not be as effective: one dose every 3 months after 4 monthly doses
- Once a month (approximately 28 days)
- Macular edema following RVO
- Once a month (approximately 28 days)
- mCNV
- Initially once a month (28 days) for up to 3 months. Patients may be retreated dependent on case presentation.
Gotcha. Now what does this interchangeable status mean?
Per the FDA, a product approved as an interchangeable biosimilar indicates that it meets the standards for “interchangeability,” where it can be substituted for a reference product without a need to consult the prescriber. This is commonly referred to as “pharmacy-level substitution”.
To note, such substitutions are considered a matter of state pharmacy law.
Essentially, a product must show that it is expected to produce the same clinical result as the reference product in any given patient.
And in this case?
In this case, per the October 3, 2023, FDA letter, Byooviz (the biosimilar) can be substituted for Lucentis (the reference product) for any of its previously approved indications (wet AMD, macular edema following RVO, and mCNV).
What happens next?
This approval provides an alternative treatment option for patients who might suffer from wet AMD, macular edema following RVO, or mCNV.