- CIMERLI®*, a ranibizumab biosimilar, is interchangeable with LUCENTIS®** (ranibizumab injection) for all approved indications
- Dedicated retina sales and field reimbursement team integrated into Sandoz, ensuring seamless experience for providers and patients
BASEL, Switzerland I March 4, 2024 I Sandoz, the global leader in generic and biosimilar medicines, has completed the acquisition of the US biosimilar CIMERLI®* (ranibizumab-eqrn) from Coherus BioSciences, Inc, ahead of anticipated timelines. The acquisition builds on the leading Sandoz ophthalmic platform in the US and lays an even stronger foundation for future product launches.
Keren Haruvi, President Sandoz North America said: “Today we further expand the Sandoz biosimilar portfolio, while advancing our mission in the US of pioneering patient access to more affordable and much-needed medicines. With the addition of CIMERLI® to our existing ophthalmology franchise, we can now offer even more treatment options for US patients with vision impairment and loss.”
CIMERLI® is indicated for the treatment of certain retinal diseases that, if left untreated, can cause vision loss, which ranks among the top 10 causes of disability in the United States.1 It is an anti-VEGF therapy within a class of biologics that helps retinal patients maintain or gain vision.2
Sandoz and Coherus entered into an agreement in January 2024 through which Sandoz agreed to acquire the full CIMERLI® business for an upfront cash purchase price of USD 170 million. The transaction includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software.
About CIMERLI®
CIMERLI®* solution for injection (6 mg/mL and 10 mg/mL) is an FDA-approved biosimilar to reference product LUCENTIS®** (ranibizumab injection) indicated for the treatment of multiple retinal diseases, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV).3 CIMERLI®* is an anti-VEGF therapy within a class of biologics that helps retinal patients maintain or gain vision.2 CIMERLI®* was approved by the FDA in August 2022, having met FDA’s rigorous standards of biosimilarity to the reference product, including safety, efficacy and quality. Launched in October 2022, it is the first and only FDA-approved biosimilar interchangeable with LUCENTIS®** for all indications.
IMPORTANT SAFETY INFORMATION & 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)
CONTRAINDICATIONS
- Ocular or periocular infections
- Hypersensitivity
WARNINGS AND PRECAUTIONS
- Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection
- Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection
- There is a potential risk of arterial thromboembolic events following intravitreal use of vascular endothelial growth factor (VEGF) inhibitors
- Fatal events occurred more frequently in patients with diabetic macular edema and diabetic retinopathy at baseline, who were treated monthly with ranibizumab compared with control
ADVERSE REACTIONS
- The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP
For additional Safety Information, please see CIMERLI® Full Prescribing Information available here.
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.
*CIMERLI® is a registered trademark of Coherus BioSciences, Inc.
**LUCENTIS® is a registered trademark of Genentech USA, Inc.
***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.
Disclaimer
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.
References
- Centers for Disease Control and Preventon. Vision Loss: A Public Health Problem. December 19, 2022. Accessed February 22, 2024. Vision Loss: A Public Health Problem | CDC
- American Academy of Ophthalmology. Anti-VEGF Treatments. July 26, 2023. Accessed February 22, 2024. Anti-VEGF Treatments – American Academy of Ophthalmology (aao.org).
- CIMERLI®. Prescribing Information. Available at Prescribing Information.
About Sandoz
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. 22,000 people of more than 100 nationalities work together to bring Sandoz medicines to some 500 million patients worldwide, generating substantial global healthcare savings and an even larger total social impact. Its leading portfolio of more than 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to the year 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the first biosimilar in 2006. In 2022, Sandoz achieved sales of USD 9.1 billion and core EBITDA of USD 1.9 billion.
SOURCE: Sandoz
Post Views: 606
- CIMERLI®*, a ranibizumab biosimilar, is interchangeable with LUCENTIS®** (ranibizumab injection) for all approved indications
- Dedicated retina sales and field reimbursement team integrated into Sandoz, ensuring seamless experience for providers and patients
BASEL, Switzerland I March 4, 2024 I Sandoz, the global leader in generic and biosimilar medicines, has completed the acquisition of the US biosimilar CIMERLI®* (ranibizumab-eqrn) from Coherus BioSciences, Inc, ahead of anticipated timelines. The acquisition builds on the leading Sandoz ophthalmic platform in the US and lays an even stronger foundation for future product launches.
Keren Haruvi, President Sandoz North America said: “Today we further expand the Sandoz biosimilar portfolio, while advancing our mission in the US of pioneering patient access to more affordable and much-needed medicines. With the addition of CIMERLI® to our existing ophthalmology franchise, we can now offer even more treatment options for US patients with vision impairment and loss.”
CIMERLI® is indicated for the treatment of certain retinal diseases that, if left untreated, can cause vision loss, which ranks among the top 10 causes of disability in the United States.1 It is an anti-VEGF therapy within a class of biologics that helps retinal patients maintain or gain vision.2
Sandoz and Coherus entered into an agreement in January 2024 through which Sandoz agreed to acquire the full CIMERLI® business for an upfront cash purchase price of USD 170 million. The transaction includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software.
About CIMERLI®
CIMERLI®* solution for injection (6 mg/mL and 10 mg/mL) is an FDA-approved biosimilar to reference product LUCENTIS®** (ranibizumab injection) indicated for the treatment of multiple retinal diseases, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV).3 CIMERLI®* is an anti-VEGF therapy within a class of biologics that helps retinal patients maintain or gain vision.2 CIMERLI®* was approved by the FDA in August 2022, having met FDA’s rigorous standards of biosimilarity to the reference product, including safety, efficacy and quality. Launched in October 2022, it is the first and only FDA-approved biosimilar interchangeable with LUCENTIS®** for all indications.
IMPORTANT SAFETY INFORMATION & 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)
CONTRAINDICATIONS
- Ocular or periocular infections
- Hypersensitivity
WARNINGS AND PRECAUTIONS
- Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection
- Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection
- There is a potential risk of arterial thromboembolic events following intravitreal use of vascular endothelial growth factor (VEGF) inhibitors
- Fatal events occurred more frequently in patients with diabetic macular edema and diabetic retinopathy at baseline, who were treated monthly with ranibizumab compared with control
ADVERSE REACTIONS
- The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP
For additional Safety Information, please see CIMERLI® Full Prescribing Information available here.
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.
*CIMERLI® is a registered trademark of Coherus BioSciences, Inc.
**LUCENTIS® is a registered trademark of Genentech USA, Inc.
***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.
Disclaimer
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.
References
- Centers for Disease Control and Preventon. Vision Loss: A Public Health Problem. December 19, 2022. Accessed February 22, 2024. Vision Loss: A Public Health Problem | CDC
- American Academy of Ophthalmology. Anti-VEGF Treatments. July 26, 2023. Accessed February 22, 2024. Anti-VEGF Treatments – American Academy of Ophthalmology (aao.org).
- CIMERLI®. Prescribing Information. Available at Prescribing Information.
About Sandoz
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. 22,000 people of more than 100 nationalities work together to bring Sandoz medicines to some 500 million patients worldwide, generating substantial global healthcare savings and an even larger total social impact. Its leading portfolio of more than 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to the year 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the first biosimilar in 2006. In 2022, Sandoz achieved sales of USD 9.1 billion and core EBITDA of USD 1.9 billion.
SOURCE: Sandoz
Post Views: 606
