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For US Healthcare Professionals

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 &
    excipients
  • Same amino
    acid sequence

Rigorous FDA determination of biosimilarity is based on the totality of evidence2

Biosimilarity

CIMERLI™ was proven to be biosimilar to Lucentis®3,4

CIMERLI™Lucentis®Molecular structureBiological functionPharmacokineticsPharmacodynamicsSafety profileImmunogenicityDrug stabilityDrug purity
CIMERLI™Lucentis®Molecular structureBiological functionPharmacokineticsPharmacodynamicsSafety profileImmunogenicityDrug stabilityDrug purity

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.

Interchangeability

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.

Study Design

  • 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
      to 20/100
PrimaryChange in BCVA from baseline at Week 8Key SecondaryChange in BCVA from baseline at Week 48, change in retina thickness from baseline at week 48, safety and immunogenicityEndpointsR 1:1n=477Treatment: CIMERLI™IVT 0.5 mg (50 μL) Q4W for ≤48 weeksn=238Reference Product: Lucentis®IVT 0.5 mg (50 μL) Q4W for ≤48 weeksn=239
EndpointsPrimaryChange in BCVA from baseline at Week 8*Key SecondaryChange in BCVA from baseline at Week 48, change in retina thickness from baseline at Week 48, safety and immunogenicityTreatment: CIMERLI™IVT 0.5 mg (50 μL) Q4W for ≤48 weeksn=238Reference Product: Lucentis®IVT 0.5 mg (50 μL) Q4W for ≤48 weeksn=239R 1:1n=477

*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

+5ETDRSletters

Primary Endpoint:
BCVA improved in both CIMERLI™ and Lucentis® treatment groups with an average of 5 more ETDRS letters at 8 weeks.

020406080100Baseline48121620243236404448Study WeekMean ETDRS Letters (±SD)CIMERLILucentis®

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.

FCP Thickness:

Mean reduction from baseline of 213.3 µm CIMERLI™ and 211.0 µm Lucentis® at Week 48.

CIMERLI™Lucentis®
FCS Thickness:

Mean reduction from baseline of 182.9 µm CIMERLI™ and 182.9 µm Lucentis® at Week 4.

CIMERLI™Lucentis®

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

No clinical differences in adverse events were observed between CIMERLI™ and Lucentis®.
Most frequently observed drug-related adverse events*AdverseReactionCIMERLI™% (n=238)Lucentis®% (n=239)CataractRetinal Pigment Epithelium TearReduced Visual AcuityPunctate KeratitisVitreousHemorrhageEye PainIncreased Gamma-GlutamylTransferase LevelIncreasedIntraocularPressureIntraocularInflammation0.0% (0)0.4% (1)0.0% (0)0.0% (0)0.4% (1)0.8% (2)0.4% (1)1.3% (3)0.8% (2)2.1% (5)1.3% (3)1.3% (3)0.8% (2)0.4% (1)0.0% (0)0.8% (2)0.8% (2)0.8% (2)
Most frequently observed drug-related adverse events*Adverse ReactionCIMERLI™% (n=238)Lucentis®% (n=239)CataractRetinal Pigment Epithelium TearReduced Visual AcuityPunctate KeratitisVitreous HemorrhageEye PainIncreased Gamma-GlutamylTransferase LevelIncreased Intraocular PressureIntraocular Inflammation0.0% (0)0.4% (1)0.0% (0)0.0% (0)0.4% (1)0.8% (2)0.4% (1)1.3% (3)0.8% (2)2.1% (5)1.3% (3)1.3% (3)0.8% (2)0.4% (1)0.0% (0)0.8% (2)0.8% (2)0.8% (2)

*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.

Bar Chart: Incidence of anti-drug antibodies, 5.9% in both treatment groupsIncidence of Anti-drug Antibodies5.9%5.9%0%20%40%60%80%100%Proportion of PatientsCIMERLI™Lucentis®
Incidence of Anti-drug Antibodies

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:

  • Nasopharyngitis
  • Anemia
  • Nausea

See the CIMERLI™ Important Safety Information and the CIMERLI™ Full Prescribing Information for more information on side effects.

References:

  1. CIMERLI™ (ranibizumab-eqrn) prescribing information. Redwood City, CA: Coherus BioSciences, Inc.
  2. Considerations in demonstrating interchangeability with a reference product. U.S. Food and Drug Administration. https://www.fda.gov/media/124907/download. Published 2019. Accessed on February 24, 2022.
  3. Holz FG, Oleksy P, Ricci F, et al. Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022;129(1):54-63. doi:10.1016/j.ophtha.2021.04.031.
  4. Data on file. Coherus BioSciences, Inc.
  5. Bressler S, Hepp R. The Biosimilar Market: What You Need to Know. Retina Today. https://retinatoday.com/articles/2022-may-june/the-biosimilar-market-what-you-need-to-know. Published 2022. Accessed on June 14, 2022.

Important Safety Information

Important Safety Information

CONTRAINDICATIONS

  • CIMERLI™ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI™. Hypersensitivity reactions may manifest as severe intraocular inflammation

WARNINGS & PRECAUTIONS

  • Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be utilized when administering CIMERLI™. Patients should be monitored following the injection to permit early treatment, should an infection occur
  • Increases in Intraocular Pressure: Increases in intraocular pressure (IOP) have been noted both pre-injection and post-injection (at 60 minutes) with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with CIMERLI™ 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 3 controlled neovascular AMD studies 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), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg 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 2 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

Diabetic macular edema and Diabetic Retinopathy

  • In a pooled analysis of Studies D-1 and D-2, the ATE rate at 2 years was 7.2% (18 of 250) with 0.5 mg ranibizumab, 5.6% (14 of 250) with 0.3 mg ranibizumab, and 5.2% (13 of 250) with control. The stroke rate at 2 years was 3.2% (8 of 250) with 0.5 mg ranibizumab, 1.2% (3 of 250) with 0.3 mg ranibizumab, and 1.6% (4 of 250) with control. At 3 years, the ATE rate was 10.4% (26 of 249) with 0.5 mg ranibizumab and 10.8% (27 of 250) with 0.3 mg ranibizumab; the stroke rate was 4.8% (12 of 249) with 0.5 mg ranibizumab and 2.0% (5 of 250) with 0.3 mg ranibizumab
  • Fatal events in patients with diabetic macular edema and diabetic retinopathy at baseline: A pooled analysis of Studies D-1 and D-2 showed that fatalities in the first 2 years occurred in 4.4% (11 of 250) of patients treated with 0.5 mg ranibizumab, in 2.8% (7 of 250) of patients treated with 0.3 mg ranibizumab, and in 1.2% (3 of 250) of control patients. Over 3 years, fatalities occurred in 6.4% (16 of 249) of patients treated with 0.5 mg ranibizumab and in 4.4% (11 of 250) of patients treated with 0.3 mg ranibizumab. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded

ADVERSE REACTIONS

  • Serious adverse events related to the injection procedure have occurred in <0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.
  • In ranibizumab-treated patients compared with the control group, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough.
  • As with all therapeutic proteins, there is the potential for an immune response in patients treated with ranibizumab products. The clinical significance of immunoreactivity to ranibizumab products is unclear at this time

Postmarketing Experience

The following adverse reaction has been identified during post-approval use of ranibizumab products:

  • Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD

*An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of CIMERLI™ has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-483-3692 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before prescribing, please see CIMERLI™ Full Prescribing Information.

Indications

Indications

CIMERLI™ (ranibizumab-eqrn) is interchangeable* to Lucentis® (ranibizumab injection)

CIMERLI™ (ranibizumab-eqrn), 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)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)
  • Myopic Choroidal Neovascularization (mCNV)

Important Safety Information

Important Safety Information

CONTRAINDICATIONS

  • CIMERLI™ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI™. Hypersensitivity reactions may manifest as severe intraocular inflammation

WARNINGS & PRECAUTIONS

  • Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be utilized when administering CIMERLI™. Patients should be monitored following the injection to permit early treatment, should an infection occur
  • Increases in Intraocular Pressure: Increases in intraocular pressure (IOP) have been noted both pre-injection and post-injection (at 60 minutes) with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with CIMERLI™ 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 3 controlled neovascular AMD studies 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), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg 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 2 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

Diabetic macular edema and Diabetic Retinopathy

  • In a pooled analysis of Studies D-1 and D-2, the ATE rate at 2 years was 7.2% (18 of 250) with 0.5 mg ranibizumab, 5.6% (14 of 250) with 0.3 mg ranibizumab, and 5.2% (13 of 250) with control. The stroke rate at 2 years was 3.2% (8 of 250) with 0.5 mg ranibizumab, 1.2% (3 of 250) with 0.3 mg ranibizumab, and 1.6% (4 of 250) with control. At 3 years, the ATE rate was 10.4% (26 of 249) with 0.5 mg ranibizumab and 10.8% (27 of 250) with 0.3 mg ranibizumab; the stroke rate was 4.8% (12 of 249) with 0.5 mg ranibizumab and 2.0% (5 of 250) with 0.3 mg ranibizumab
  • Fatal events in patients with diabetic macular edema and diabetic retinopathy at baseline: A pooled analysis of Studies D-1 and D-2 showed that fatalities in the first 2 years occurred in 4.4% (11 of 250) of patients treated with 0.5 mg ranibizumab, in 2.8% (7 of 250) of patients treated with 0.3 mg ranibizumab, and in 1.2% (3 of 250) of control patients. Over 3 years, fatalities occurred in 6.4% (16 of 249) of patients treated with 0.5 mg ranibizumab and in 4.4% (11 of 250) of patients treated with 0.3 mg ranibizumab. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded

ADVERSE REACTIONS

  • Serious adverse events related to the injection procedure have occurred in <0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.
  • In ranibizumab-treated patients compared with the control group, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough.
  • As with all therapeutic proteins, there is the potential for an immune response in patients treated with ranibizumab products. The clinical significance of immunoreactivity to ranibizumab products is unclear at this time

Postmarketing Experience

The following adverse reaction has been identified during post-approval use of ranibizumab products:

  • Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD

*An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of CIMERLI™ has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-483-3692 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before prescribing, please see CIMERLI™ Full Prescribing Information.

Indications

Indications

CIMERLI™ (ranibizumab-eqrn) is interchangeable* to Lucentis® (ranibizumab injection)

CIMERLI™ (ranibizumab-eqrn), 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)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)
  • Myopic Choroidal Neovascularization (mCNV)

Important Safety Information

CONTRAINDICATIONS: CIMERLI™ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI™. Hypersensitivity reactions may manifest as severe intraocular inflammation

Important Safety Information

Important Safety Information

CONTRAINDICATIONS

  • CIMERLI™ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI™. Hypersensitivity reactions may manifest as severe intraocular inflammation

WARNINGS & PRECAUTIONS

  • Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be utilized when administering CIMERLI™. Patients should be monitored following the injection to permit early treatment, should an infection occur
  • Increases in Intraocular Pressure: Increases in intraocular pressure (IOP) have been noted both pre-injection and post-injection (at 60 minutes) with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with CIMERLI™ 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 3 controlled neovascular AMD studies 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), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg 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 2 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

Diabetic macular edema and Diabetic Retinopathy

  • In a pooled analysis of Studies D-1 and D-2, the ATE rate at 2 years was 7.2% (18 of 250) with 0.5 mg ranibizumab, 5.6% (14 of 250) with 0.3 mg ranibizumab, and 5.2% (13 of 250) with control. The stroke rate at 2 years was 3.2% (8 of 250) with 0.5 mg ranibizumab, 1.2% (3 of 250) with 0.3 mg ranibizumab, and 1.6% (4 of 250) with control. At 3 years, the ATE rate was 10.4% (26 of 249) with 0.5 mg ranibizumab and 10.8% (27 of 250) with 0.3 mg ranibizumab; the stroke rate was 4.8% (12 of 249) with 0.5 mg ranibizumab and 2.0% (5 of 250) with 0.3 mg ranibizumab
  • Fatal events in patients with diabetic macular edema and diabetic retinopathy at baseline: A pooled analysis of Studies D-1 and D-2 showed that fatalities in the first 2 years occurred in 4.4% (11 of 250) of patients treated with 0.5 mg ranibizumab, in 2.8% (7 of 250) of patients treated with 0.3 mg ranibizumab, and in 1.2% (3 of 250) of control patients. Over 3 years, fatalities occurred in 6.4% (16 of 249) of patients treated with 0.5 mg ranibizumab and in 4.4% (11 of 250) of patients treated with 0.3 mg ranibizumab. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded

ADVERSE REACTIONS

  • Serious adverse events related to the injection procedure have occurred in <0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.
  • In ranibizumab-treated patients compared with the control group, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough.
  • As with all therapeutic proteins, there is the potential for an immune response in patients treated with ranibizumab products. The clinical significance of immunoreactivity to ranibizumab products is unclear at this time

Postmarketing Experience

The following adverse reaction has been identified during post-approval use of ranibizumab products:

  • Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD

*An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of CIMERLI™ has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-483-3692 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before prescribing, please see CIMERLI™ Full Prescribing Information.

Indications

CIMERLI™ (ranibizumab-eqrn) is interchangeable* to Lucentis® (ranibizumab)

CIMERLI™ (ranibizumab-eqrn), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:

Indications

Indications

Indications

CIMERLI™ (ranibizumab-eqrn) is interchangeable* to Lucentis® (ranibizumab injection)

CIMERLI™ (ranibizumab-eqrn), 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)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)
  • Myopic Choroidal Neovascularization (mCNV)

Proven vision gains at 8 weeks
and sustained through Week 48

Bar Chart: Vision gains at 8 weeks and sustained through Week 483

Study Week

Demonstrated sustained reduction in
retinal thickness through Week 48 (FCP)

Bar Chart: Reduction in FCP retinal thickness

Study Week

Demonstrated sustained reduction in
retinal thickness through Week 48 (FCS)

Bar Chart: Reduction in FCS retinal thickness

Study Week

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