BRINGING BIOSIMILAR SCIENCE TO CERTAIN RETINAL VASCULAR DISORDERS1

BYOOVIZ: A Biosimilar* Referencing Lucentis1

  • FDA-approved for the treatment of nAMD, macular edema following RVO, and mCNV1
  • Similar efficacy and comparable safety and immunogenicity to Lucentis2,3
  • No clinically meaningful differences from Lucentis based on the totality of evidence2,3
  • 0.5 mg (0.05 mL of 10 mg/mL) dosing administered by intravitreal injection once a month1

*

Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.

BYOOVIZ Met FDA Requirements for Biosimilar Approval in All Studies Conducted2-5

BYOOVIZ Met FDA Requirements for Biosimilar Approval in All Studies Conducted2-5

BYOOVIZ was evaluated for biosimilarity in an nAMD clinical study and was granted approval for macular edema following RVO and mCNV through a process called "extrapolation." Extrapolation of clinical data to other indications of the reference product is considered in light of the totality of evidence and must be scientifically justified.1-6

BYOOVIZ is FDA-approved for the treatment of nAMD, macular edema following RVO, and mCNV1
FDA=US Food and Drug Administration; mCNV=myopic choroidal neovascularization; nAMD=neovascular age-related macular degeneration; RVO=retinal vein occlusion.
Indication and Important
Safety Information
INDICATIONS
BYOOVIZ® (ranibizumab-nuna), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:
  • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Myopic Choroidal Neovascularization (mCNV)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
  • BYOOVIZ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in BYOOVIZ
  • Hypersensitivity reactions may manifest as severe intraocular inflammation
WARNINGS AND PRECAUTIONS Endophthalmitis and Retinal Detachments
  • Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis, retinal detachments, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be used when administering BYOOVIZ. In addition, patients should be monitored following the injection to permit early treatment, should an infection occur
Increases in Intraocular Pressure
  • Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with BYOOVIZ and manage appropriately
Thromboembolic Events
  • Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause)
  • Neovascular (Wet) Age-Related Macular Degeneration

    • The ATE rate in the three controlled neovascular AMD studies (AMD-1, AMD-2, AMD-3) during the first year was 1.9% (17 of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab compared with 1.1% (5 of 441) in patients from the control arms. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 of 721) in the combined group of ranibizumab-treated patients compared with 2.9% (10 of 344) in patients from the control arms. In Study AMD-4, the ATE rates observed in the 0.5 mg arms during the first and second year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3

      In a pooled analysis of 2-year controlled studies [AMD-1, AMD-2, and a study of ranibizumab used adjunctively with verteporfin photodynamic therapy (PDT)], the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg of ranibizumab compared to 1.1% (5 of 435) in patients in the control arms [odds ratio 2.2 (95% confidence interval; 0.8-7.1)]

  • Macular Edema Following Retinal Vein Occlusion
    • The ATE rate in the two controlled RVO studies during the first 6 months was 0.8% in both the ranibizumab and control arms of the studies (4 of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab and 2 of 260 in the control arms). The stroke rate was 0.2% (1 of 525) in the combined group of ranibizumab-treated patients compared to 0.4% (1 of 260) in the control arms
Retinal Vasculitis With or Without Occlusion
  • Retinal vasculitis with or without occlusion, typically in the presence of preexisting intraocular inflammation or post-treatment with other intravitreal agents, have been reported with the use of ranibizumab products. Discontinue treatment with BYOOVIZ in patients who develop these events. Patients should be instructed to report any change in vision without delay

ADVERSE REACTIONS

  • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract
  • The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular adverse reactions included nasopharyngitis, anemia, nausea, and cough
  • As with all therapeutic proteins, there is potential for immunogenicity. The clinical significance of immunoreactivity to ranibizumab products is unclear at this time

You are encouraged to report suspected adverse reactions to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.

References

  1. BYOOVIZ Prescribing Information, Harrow IP, LLC.
  2. Woo SJ, Veith M, Hamouz J, et al. Efficacy and safety of a proposed ranibizumab biosimilar product vs a reference ranibizumab product for patients with neovascular age-related macular degeneration: a randomized clinical trial. JAMA Ophthalmol. 2021;139(1):68-76. doi:10.1001/jamaophthalmol.2020.5053
  3. Bressler NM, Veith M, Hamouz J, et al. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes. Br J Ophthalmol. 2021;bjophthalmol-2021-319637. doi:10.1136/bjophthalmol-2021-319637
  4. US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Silver Spring, MD: FDA, US Dept of Health and Human Services;. April 2015.
  5. US Food and Drug Administration. Multi-discipline review. Center for Drug Evaluation and Research application number 761202Orig1s00. Byooviz Multi-Discipline Review. https://www.accessdata.fda.gov/​drugsatfda_docs/nda/2021/​761202Orig1s000MultidisciplineR.pdf. Accessed January 15, 2025.
  6. Wolff-Holz E, Garcia Burgos J, Giuliani R, et al. Preparing for the incoming wave of biosimilars in oncology. ESMO Open. 2018;3(6):e000420. doi:10.1136/esmoopen-2018-000420