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For US Healthcare Professionals

Biosimilars can expand patient access to important cost‑effective therapies

While effective and necessary, biologics can be costly

Biologics account for >40% of all US prescription drug spending but account for only a small percentage of prescription drug use1,2

In 2021 alone, US biologic
spending totaled

$256 billion3

In 2021, Medicare Part B spent over $4 billion on intravitreal anti-VEGF therapy4*

OVER $1 BILLION

Ranibizumab

OVER $3 BILLION

Aflibercept

Ranibizumab and aflibercept accounted for 11% of Medicare Part B spend before the entry of biosimilars.4

*Expenditure cites Medicare Part B only. It does not include spend by other government and commercial payers, such as spend for Medicare Advantage members.

The Biologics Price Competition and Innovation (BPCI) Act of 2009 was enacted as part of the Affordable Care Act, which created an FDA registration pathway for biologics to demonstrate biosimilarity, as a concerted effort to5,6:

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Provide more
treatment options

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Lower healthcare costs
through competition

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Increase access to
lifesaving medications

The rigorous FDA biosimilars approval pathway

The BPCI Act established a rigorous registration pathway for biosimilars in the US, promoting the
development of more cost-effective treatment options, without compromising efficacy and safety.5,6

Biosimilar development characterized as a pyramid, starting with in vitro studies, analytical characterization, at the bottom, followed by in vivo studies, nonclinical. Next, clinical pharmacology, PK/PD, ending with clinical studies to review safety, efficacy and immunogenicity

Reference product development

Demonstrate safety and effectiveness with adequate and well-controlled substantial evidence for a new product.6

Grayscale Development Pyramid

Biosimilar development

Demonstrate high similarity to reference product with no clinically meaningful difference in safety, purity, and potency via in vitro, in vivo, and clinical studies.7

FDA-approval process for biosimilars

*Preclinical refers to the reference product approval pathway. Toxicity study refers to the biosimilar approval pathway and could be conducted as part of the analytical or clinical study.

Biosimilars 101: Defining key terms and exploring FDA approval

Peter Kaiser, MD (Cleveland Clinic Lerner College of Medicine) and Dilsher Dhoot, MD (California Retina Consultants)

Watch experts in the field discuss a range of topics related to biosimilars.

Explore More in the Expert Exchange

Biosimilars are tracked as part of a post-market surveillance
to ensure continued safety beyond manufacturing.8

Biosimilars increase choice in the marketplace, resulting in realized and projected savings for the healthcare system

The first biosimilar was approved in 2015. As of July 2023, at least 40 biosimilars have been approved by the FDA across a wide range of therapeutic areas, including9:

  • Oncology
  • Endocrinology
  • Rheumatology

For ophthalmology, CIMERLI® is the first and only FDA-approved biosimiliar interchangeable with Lucentis® (ranibizumab injection) for all indications.11

Hear From a Peer on CIMERLI® & Interchangeability
Biosimilars are projected to save the healthcare system $125—237 billion. From 2012 through 2022, biosimilars saved $56 billionBiosimilars are projected to save the healthcare system $125—237 billion. From 2012 through 2022, biosimilars saved $56 billion

†Savings over the next 5 years are dependent on government policy changes to support adoption.

CIMERLI® was proven clinically equivalent to Lucentis® in terms of efficacy and safety12

See Head-to-head Data

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Important Safety Information

Important Safety Information

CONTRAINDICATIONS: CIMERLI® (ranibizumab-eqrn) 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 AND PRECAUTIONS

  • Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering CIMERLI®. 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 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 (wAMD)

  • 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), 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 (RVO)

  • 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

Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)

  • 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 occurred more frequently in patients with DME and DR 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
  • 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 CIMERLI® 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 that occurred in <0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract
  • The most frequently reported ocular adverse reactions in ranibizumab-treated patients compared with the control group were conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular adverse reactions were 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

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz, Inc at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch (opens in a new tab).

Before prescribing, please see CIMERLI® Prescribing Information (opens in a new tab).

Indications

Indications

CIMERLI® is indicated for the treatment of patients with:

  • Neovascular (wet) Age-Related Macular Degeneration (wAMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)
  • Myopic Choroidal Neovascularization (mCNV)

References:

  1. Aitken M, Kleinrock M, Muñoz E. Biosimilars In The United States 2020–2024. IQVIA Institute for Human Data Science; 2020. https://www.iqvia.com/-/‌media/‌iqvia/‌pdfs/‌institute-reports/‌iqvia-institute-biosimilars-in-the-united-states.pdf. Accessed on July 26, 2023.
  2. Makurvet F. Biologics vs. small molecules: drug costs and patient access. Med Drug Discov. 2021;9:100075. doi:10.1016/j.medidd.2020.100075
  3. Cavazzoni P. FDA and FTC Collaborate to Advance Competition in the Biologic Marketplace. U.S. Food and Drug Administration. https://www.fda.gov/news-events/fda-voices/fda-and-ftc-collaborate-advance-competition-biologic-marketplace. Updated March 2, 2023. Accessed July 26, 2023.
  4. Centers for Medicare & Medicaid Services. Medicare Part B Spending by Drug. https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-spending-by-drug/data. Accessed July 26, 2023.
  5. Biologics Price Competition and Innovation Act Of 2009. US Food and Drug Administration. https://www.fda.gov/media/78946/download. Published 2009. Accessed on July 26, 2023.
  6. Dougherty M, Zineh I, Christl L. Perspectives on the Current State of the Biosimilar Regulatory Pathway in the United States. Clin Pharmacol Ther. 2018;103(1):36-38. doi:10.1002/cpt.909
  7. Considerations in demonstrating interchangeability with a reference product. US Food and Drug Administration. https://www.fda.gov/media/124907/download. Published 2019. Accessed on July 26, 2023.
  8. What is a Biosimilar? U.S. Food and Drug Administration. https://www.fda.gov/media/108905/download. Accessed July 26, 2023.
  9. Biosimilar Product Information. U.S. Food and Drug Administration. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Updated May 25, 2023. Accessed July 26, 2023.
  10. Biosimilars in the United States 2023-2027: Competition, Savings, Sustainability. The IQIVIA Institute.
  11. CIMERLI® (ranibizumab-eqrn) prescribing information. Princeton, NJ: Sandoz Inc.
  12. 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

Important Safety Information

Important Safety Information

CONTRAINDICATIONS: CIMERLI® (ranibizumab-eqrn) 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 AND PRECAUTIONS

  • Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering CIMERLI®. 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 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 (wAMD)

  • 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), 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 (RVO)

  • 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

Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)

  • 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 occurred more frequently in patients with DME and DR 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
  • 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 CIMERLI® 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 that occurred in <0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract
  • The most frequently reported ocular adverse reactions in ranibizumab-treated patients compared with the control group were conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular adverse reactions were 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

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz, Inc at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch (opens in a new tab).

Before prescribing, please see CIMERLI® Prescribing Information (opens in a new tab).

Indications

Indications

CIMERLI® is indicated for the treatment of patients with:

  • Neovascular (wet) Age-Related Macular Degeneration (wAMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)
  • Myopic Choroidal Neovascularization (mCNV)

Important Safety Information

CONTRAINDICATIONS: CIMERLI® (ranibizumab-eqrn) 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® (ranibizumab-eqrn) 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 AND PRECAUTIONS

  • Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering CIMERLI®. 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 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 (wAMD)

  • 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), 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 (RVO)

  • 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

Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)

  • 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 occurred more frequently in patients with DME and DR 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
  • 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 CIMERLI® 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 that occurred in <0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract
  • The most frequently reported ocular adverse reactions in ranibizumab-treated patients compared with the control group were conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular adverse reactions were 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

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz, Inc at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch (opens in a new tab).

Before prescribing, please see CIMERLI® Prescribing Information (opens in a new tab).

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® is indicated for the treatment of patients with:

  • Neovascular (wet) Age-Related Macular Degeneration (wAMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)
  • Myopic Choroidal Neovascularization (mCNV)

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