BCVA improved in both CIMERLI™ and Lucentis® treatment groups with an average of 5 more ETDRS letters at 8 weeks.
CIMERLI™ is the first and only FDA-approved biosimilar interchangeable with Lucentis® for all indications1
CIMERLI™ has attributes identical to Lucentis®:
- Same FDA-approved indications
- Same dosage strengths
(0.3 mg & 0.5 mg)
- Same formulation &
- Same amino
Rigorous FDA determination of biosimilarity is based on the totality of evidence2
CIMERLI™ was proven to be biosimilar to Lucentis®3,4
CIMERLI™ was proven to be highly similar to Lucentis® with no clinically meaningful differences3
Totality of Evidence
CIMERLI™ meets rigorous FDA requirements for biosimilarity
Comparative analytical studies
Demonstrate similarity of the structural and functional quality attributes of CIMERLI™ to Lucentis®4
Comparative animal studies
Establish ocular pharmacokinetics comparable to Lucentis® in rabbit model (within the vitreous humor)4
Comparative clinical study
Demonstrate no clinically meaningful differences in terms of efficacy, safety, and immunogenicity, as well as pharmacokinetic and pharmacodynamic evaluation in wAMD patients (COLUMBUS-AMD study)3,4
CIMERLI™ is approved for DR, DME, macular edema following RVO, and mCNV indications based on extrapolation from wAMD1,2
Extrapolation is a scientific rationale that bridges the totality of evidence from one indication for the biosimilar product to all indications originally approved for the reference product.3
CIMERLI™ extrapolation is based on scientific justification.
- Reference product’s safety and efficacy results for DR, DME, macular edema following RVO, and mCNV
- Knowledge and consideration of various scientific factors:
- Mechanism of action in each condition of use
- Pharmacokinetics and biodistribution in different patient populations
- Immunogenicity in different patient populations
- Differences in expected toxicities in each condition of use and patient populations
DR, diabetic retinopathy; DME, diabetic macular edema; RVO, retinal vein occlusion; mCNV, myopic choroidal neovascularization; wAMD, neovascular (wet) age-related macular degeneration.
CIMERLI™ is the first and only biosimilar interchangeable with Lucentis® for all FDA-approved indications1
The FDA requires an interchangeable product to demonstrate2:
- That it is biosimilar to the reference product
- That it can be expected to produce the same clinical results in any given patient for all FDA-approved indications
- That it does not increase risk, in terms of safety or reduction of efficacy when alternating or switching between the biosimilar and its reference product
A biologic approved as interchangeable means the FDA has concluded it may be substituted for the reference product.2
CIMERLI™ meets rigorous FDA requirements for interchangeability based on its totality of evidence, demonstrating2-4:
- Equivalent chemical and biological structure and function
- Comparable efficacy and safety profile
- Low systemic exposure
- Low immunogenicity rate
Be confident CIMERLI™ can be substituted for Lucentis® in any given patient.
The COLUMBUS-AMD comparative study3
A head-to-head study of CIMERLI™ vs reference product Lucentis® published in Ophthalmology, the journal of the American Academy of Ophthalmology.
- A prospective 48-week, evaluation-blinded, parallel-group, global, multicenter, randomized study in patients with treatment-naïve, subfoveal CNV due to wAMD
- Patient characteristics were well balanced between study arms:
- ≥50 years
- Subfoveal or juxtafoveal CNV with foveal-involving leakage related to CNV activity
- FCP retinal thickness ≥350 µm on SD-OCT
- Total lesion area of ≤12 MPS disc areas
- Total CNV area ≥50% of total lesion area
- Study eye BCVA 20/32
*FDA required primary endpoint selection of BCVA at 8 weeks3,5
The 8-week primary endpoint is considered highly sensitive to detect any difference between the biosimilar and reference product because rate of improvement in visual acuity is particularly steep during the first 8 weeks. Odds of observing a true difference in efficacy between CIMERLI™ and Lucentis® would be seen during this timeframe.
BCVA, best corrected visual acuity; CNV, choroidal neovascularization; ETDRS, Early Treatment Diabetic Retinopathy Study; FCP, foveal center point; IVT, intravitreal; MPS, macular photocoagulation study; wAMD, neovascular (wet) age-related macular degeneration; Q4W, every 4 weeks; R, randomized; SD-OCT, spectral domain optical coherence tomography.
CIMERLI™ head-to-head clinical trial established clinical equivalence to Lucentis®
Proven vision gains at 8 weeks and sustained through Week 483
Demonstrated sustained reduction in retinal thickness through Week 483
Secondary Endpoint: Patients in both treatment groups experienced highly similar reductions in FCP and FCS
retinal thickness, as well as total lesion area.
Mean reduction from baseline of 213.3 µm CIMERLI™ and 211.0 µm Lucentis® at Week 48.
Mean reduction from baseline of 182.9 µm CIMERLI™ and 182.9 µm Lucentis® at Week 4.
FCP = foveal center point; FCS = foveal central subfield.
Take a closer look at the head-to-head trial results between CIMERLI™ and Lucentis®Review the COLUMBUS-AMD Study
CIMERLI™ demonstrated a comparable safety profile to Lucentis®3
*Among CIMERLI™ patients, one case of iridocyclitis and one case of conjunctivitis were observed.
Two cases of punctate keratitis were observed among Lucentis® patients.
CIMERLI™ demonstrated an immunogenicity profile comparable to Lucentis®3
- Few patients developed anti-drug antibodies (ADAs) during the study and had similar levels of ADA titers across treatment arms†
- No neutralizing antibodies (NAbs) were detected up to Week 24
- 1 patient tested positive for NAbs up to Week 48 (CIMERLI™)
†The clinical significance of immunoreactivity to ranibizumab is unclear at this time.
Injection-site reactions are common with intravitreal injections1
Serious side effects include infections inside of the eye and detached retinas that may cause:
- Blurry vision
- Light sensitivity
- Cloudy vision
Some patients have had increased eye pressure before and within 1 hour of an injection.
Uncommonly, CIMERLI™ patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes. Although there were only a few fatal events, which included causes of death typical of patients with advanced diabetic complications, these events may be caused by CIMERLI™.
The most common eye-related side effects are:
- Conjunctival hemorrhage
- Eye pain
- Eye floaters
- Increased intraocular pressure
The most common non-eye related side effects are:
See the CIMERLI™ Important Safety Information and the CIMERLI™ Full Prescribing Information for more information on side effects.