Evicenter
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AXPAXLI (axitinib intravitreal implant)

Neovascular age-related macular degeneration

Also known as OTX-TKI
Manufacturer
Ocular Therapeutix
Last updated
309 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatmentCurrent treatment options and standard of care

Anti-VEGF biosimilars

8 evidence topics · 8 sources

FDA-approved ranibizumab and aflibercept biosimilars
Nonproprietary nameBiosimilar productApproval dateReference product
Ranibizumab-nuna“Byooviz (ranibizumab-nuna)”“September 2021”“Lucentis (ranibizumab)”
Ranibizumab-eqrn“Cimerli (ranibizumab-eqrn)”“August 2022”“Lucentis (ranibizumab)”
Ranibizumab-leyk“Nufymco (ranibizumab-leyk)”“December 2025”“Lucentis (ranibizumab)”
Ranibizumab-hkdz“Ranluspec (ranibizumab-hkdz)”“June 2026”“Lucentis (ranibizumab)”
Aflibercept-yszy“Opuviz (aflibercept-yszy)”“May 2024”“Eylea (aflibercept)”
Aflibercept-jbvf“Yesafili (aflibercept-jbvf)”“May 2024”“Eylea (aflibercept)”
Aflibercept-mrbb“Ahzantive (aflibercept-mrbb)”“June 2024”“Eylea (aflibercept)”
Aflibercept-abzv“Enzeevu (aflibercept-abzv)”“August 2024”“Eylea (aflibercept)”
Aflibercept-ayyh“Pavblu (aflibercept-ayyh)”“August 2024”“Eylea (aflibercept)”
Aflibercept-boav“Eydenzelt (aflibercept-boav)”“October 2025”“Eylea (aflibercept)”
AAO Preferred Practice Pattern: biosimilar approval standard and product choice

“Ophthalmic biosimilars require one comparative trial of 9 months or more for AMD demonstrating safety and efficacy compared with the reference product.” (opens the source at this quote in a new tab)

“They have no clinically meaningful differences from the reference product except in inactive components, or excipients, which can have implications for safety.” (opens the source at this quote in a new tab)

“There are no prospective long-term clinical data comparing ranibizumab biosimilars to ranibizumab.” (opens the source at this quote in a new tab)

“When used, the choice of biologic product (reference, biosimilar, or interchangeable) should be that of the treating ophthalmologist and the patient because patients may respond more favorably to one biologic over another.” (opens the source at this quote in a new tab)

AAO Preferred Practice Pattern: aflibercept biosimilar dosing

“All are injected intravitreally as a 2-mg solution, and the adverse events appear comparable to aflibercept. The recommended dose for all five agents is 2 mg every 4 weeks for the first 12 weeks, followed by 2 mg every 8 weeks.” (opens the source at this quote in a new tab)

Ranibizumab-nuna: biosimilar labeling and dosing

“BYOOVIZ (ranibizumab-nuna) is biosimilar 1 to LUCENTIS (ranibizumab injection)” (opens the source at this quote in a new tab)

“BYOOVIZ 0.5 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days).” (opens the source at this quote in a new tab)

Ranibizumab-eqrn and aflibercept-ayyh: biosimilar labeling

“CIMERLI (ranibizumab-eqrn) is biosimilar* to LUCENTIS® (ranibizumab injection).” (opens the source at this quote in a new tab)

“PAVBLU (aflibercept-ayyh) is biosimilar* to EYLEA® (aflibercept).” (opens the source at this quote in a new tab)

Ranibizumab biosimilar SB11: phase 3 equivalence trial

“This randomized, double-masked, parallel-group phase 3 equivalence study was conducted in 75 centers in 9 countries from March 14, 2018, to December 9, 2019, among 705 participants 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions.” (opens the source at this quote in a new tab)

“Least-squares mean (SE) changes in BCVA from baseline at week 8 were 6.2 (0.5) letters in the SB11 group vs 7.0 (0.5) letters in the ranibizumab group, with an adjusted treatment difference of −0.8 letter (90% CI, −1.8 to 0.2 letters).” (opens the source at this quote in a new tab)

“Immunogenicity was low, with a cumulative incidence of antidrug antibodies up to week 24 of 3.0% (10 of 330) in the SB11 group and 3.1% (10 of 327) in the ranibizumab group.” (opens the source at this quote in a new tab)

Ranibizumab biosimilar FYB201: COLUMBUS-AMD equivalence trial

“A total of 477 patients were randomly assigned to receive FYB201 (n = 238) or reference ranibizumab (n = 239).” (opens the source at this quote in a new tab)

“The analysis of covariance (ANCOVA) least squares mean difference for the change from baseline between FYB201 and reference ranibizumab was -0.4 ETDRS letters with a 90% confidence interval (CI) of -1.6 to 0.9.” (opens the source at this quote in a new tab)

AAO Preferred Practice Pattern: Medicare prices and modeled savings from biosimilars

“Medicare Part B average sales prices for ranibizumab 0.3 mg, ranibizumab 0.5 mg, and aflibercept 2 mg were $776, $1,292, and $1,806, respectively, as of October 2022.” (opens the source at this quote in a new tab)

“The model predicted that a bevacizumab biosimilar priced at $500 would increase Medicare Part B costs by $457 million annually, and one priced at $900 would increase costs by $897 million annually. However, switching from ranibizumab and aflibercept 2 mg to their biosimilars could lead to total cost savings of $132 million for Medicare.” (opens the source at this quote in a new tab)