Skip to main content

For US Healthcare Professionals

CIMERLI patient and provider support

CIMERLI Solutions™ helps ease administrative burdens and streamlines patient access

At Coherus BioSciences, we’re committed to ensuring that patients have access to treatment. CIMERLI Solutions™, part of the Coherus Solutions™ family of support services, is a comprehensive suite of patient assistance, industry-leading electronic services, and office support to ensure successful access and reimbursement.

Pre-register for CIMERLI Solutions™

Comprehensive reimbursement services to support your practice

CIMERLI Solutions™ offers reimbursement solutions you can count on:

Benefit Verification Support

Determine treatment coverage through electronic medical benefit verification

Prior Authorization Support

Ease administration burden with support for required prior authorizations or predeterminations*

Coding and Billing Support

Sample coding and billing information is available to help facilitate appropriate claims submission

Patient Financial Assistance

CIMERLI™ may be available to your patients at no cost

Appeals Assistance

Resources to help you confirm the medical necessity of CIMERLI™ and appeal denied claims§

Product Replacement

Assistance with product replacement

*If your patient's request for required authorizations isn't granted, your field reimbursement manager can work with you to determine next steps.

†Eligibility requirements, type of assistance, and application process varies.

‡Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. CIMERLI Solutions™ does not make any representation or guarantee concerning reimbursement or coverage for any service or item.

§CIMERLI Solutions™ cannot complete or submit appeals on your behalf.

3 ways to connect with CIMERLI Solutions™

Visit CIMERLI Solutions to pre-register your account

Call 1-844-483-3692
for reimbursement
support

Contact your field reimbursement manager for education and complex reimbursement issues

CO-PAY SAVINGS PROGRAM

Your patients may pay as little as $0 for CIMERLI™

The Co-Pay Savings Program may cover out-of-pocket costs associated with CIMERLI™ and the injection
procedure for eligible patients with commercial insurance.*

Icon: Pay as little as $0

per dose
of CIMERLI™

Maximum annual benefit of $15,000 for
drug costs per calendar year.

Icon: Pay as little as $0

per injection
of CIMERLI™

Maximum annual benefit of $1,000 for
injection costs per calendar year.

*Drug and Administration Co-Pay Eligibility Criteria:

  • Be prescribed CIMERLI™ for a medically appropriate purpose consistent with its FDA-approved labeling within 180 days of program enrollment
  • Have commercial (private or non-governmental) health insurance that covers the medication costs of CIMERLI™
  • Over the age of 18 years old and a US resident
  • For Administration: Not a resident or get treatments in Minnesota, Rhode Island
    • If a resident of Massachusetts, injection administration may only be paid directly to the patient. Additional information may be required
  • Not covered by any federal, state, or government-funded healthcare program, such as Medicare, Medicare Advantage, Medicare Part D, Veterans Affairs, Department of Defense, or TRICARE
  • Not seek reimbursement from any third party, including payers, charitable foundations, or flexible spending account (FSAs) or healthcare savings accounts (HSAs) for all or any part of the benefit received by Coherus through this program
  • Other restrictions apply, see Terms & Conditions
  • It is not valid for cash-paying patients or where prohibited by law
  • CIMERLI™ co-pay program subject to change or discontinuation without notice. This is not health insurance

†Terms & Conditions

Coherus’ Drug Co-pay Program and Administration Co-pay Program are different programs with unique eligibility for each. Patients must enroll separately as needed. To receive co-pay assistance for drug or administration co-pay costs, the provider, patient, or caregiver must enroll eligible individual within 180 days after the date of service for which the subsidy is sought.

Participating patients, pharmacies, physician offices and hospitals may use Coherus’ patient services web portal or send completed enrollment forms to 1-877-226-6370 to enroll patients.

Under the CIMERLI™ Drug Co-Pay program, if a patient incurs a co-pay obligation for the cost of CIMERLI™, and meets all eligibility requirements, Coherus shall subsidize the cost of drug up to $15,000 per calendar year.

Under the CIMERLI™ Injection Administration Co-Pay program, if a patient incurs a co-pay obligation for the administration of CIMERLI™, and meets all eligibility requirements, Coherus shall subsidize the cost of administration up to $1,000 per calendar year.

The program benefits will reset every January 1st. Re-enrollment in the programs is required at regular intervals. Patients may participate in the programs as long as patient re-enrolls as required by Coherus BioSciences and continues to meet all of the eligibility requirements for each program during participation in the programs. After reaching the maximum benefit for either program, the patient will be responsible for all remaining out-of-pocket expenses. The amount of each of the program’s benefits cannot exceed the patient’s out-of-pocket expenses for the cost of the drug or administration fees associated with CIMERLI™.

The programs are not valid if the costs are eligible to be reimbursed in their entirety by private insurance plans or other programs. The programs are not valid for patients receiving assistance from any other third party, including charitable organizations, if assistance is for the same expenses covered by the programs. The administration assistance cannot be combined with any other rebate, free trial, or similar offer for the medication or administration of the product unless otherwise permitted by Coherus. These programs are not health insurance or a benefit plan.

All participants are responsible for reporting the receipt of all program benefits as required by any insurer or by law. The programs are only valid in the United States and U.S. Territories and otherwise void where prohibited by law, including in Minnesota and Rhode Island. (In Massachusetts special conditions apply.) The injection administration co-pay may only be paid directly to the patient. Additional information may be required to facilitate payment directly to the patient. Program benefits may not be sold, purchased, traded or offered for sale.

The programs do not obligate use of any specific product or provider. Healthcare providers may not advertise or otherwise use the programs as a means of promoting their services or Coherus products to patients. Coherus reserves the right to rescind, revoke, or amend the program without notice at any time.

Coherus’s Co-Pay Savings Program covers the cost of medication and administration and does not cover costs associated with the office visit.

Financial assistance for greater patient access to quality treatment

Whether your patients are commercially insured, uninsured, underinsured, or on Medicare, CIMERLI Solutions™
has assistance programs to help ease payment concerns and decrease the cost of treatment.

Patient assistance program

Uninsured or underinsured patients may receive CIMERLI™ at no cost

CIMERLI™ may be available to your patients at no cost if they have no insurance or if their insurance does not cover CIMERLI™ or another drug in this class.

Patient Assistance Eligibility

Patients must be either: (a) uninsured; (b) functionally underinsured§; or (c) traditional Medicare FFS insured patient(s) that demonstrate financial hardship and cannot afford their cost-sharing obligation as evidenced by a signed attestation from their provider.

Additionally, patients must

  • Have an adjusted annual household income of ≤500% of Federal Poverty Level (FPL)
  • Complete and sign consent form and, when applicable, provide income documentation
  • Be under the care of a U.S. licensed provider, and receive CIMERLI™ in an established practice located in the U.S. incident to the prescribing physician’s professional services in the outpatient setting
  • Be a U.S. resident of any U.S. state or territory
  • Have diagnosis and dosing that are consistent with FDA-approved indication for CIMERLI™
  • Not have any other financial support options

§To be considered underinsured, the patient does not have coverage for CIMERLI™ or any other anti-VEGF or ranibizumab product.

Independent foundation support

Assistance with out-of-pocket costs

Charitable organizations may be able to provide financial assistance if your patients have commercial insurance or governmental insurance, including Medicare and Medicaid.

For retinal conditions, contact:

For macular conditions, contact:

Your patient can contact these independent foundations directly, or a CIMERLI Solutions™ patient access specialist can help determine if they are eligible at 1-844-483-3692.

‖Independent foundations have their own rules for eligibility. Coherus Biosciences has no involvement or influence in independent foundation decision-making or eligibility criteria.

Pre-register for the CIMERLI Solutions™ Portal

Setting up an account now helps ensure you'll have access to patient and provider support as soon as CIMERLI™ becomes available.

Pre-register for CIMERLI Solutions™

References:

  1. 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.
  2. Overview of the Regulatory Framework and FDA’s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US. U.S. Food and Drug Administration. https://www.fda.gov/media/113820/download. Published 2018. Accessed on February 22, 2022.
  3. Boccia R, Jacobs I, Popovian R, de Lima Lopes G Jr. Can biosimilars help achieve the goals of US health care reform? Cancer Manag Res. 2017;9:197-205. doi:10.2147/CMAR.S133442.

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)

You are now
leaving CIMERLI.com

Coherus BioSciences is not responsible for the content of linked third-party websites. Please be aware that the privacy policies and terms of use on these sites are different from Coherus BioSciences policies.