The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Ranibizumab or combination of Ranibizumab And Dexamethasone under pro re nata treatment regimen for Diabetic Macular Edema patients.

Start Date31 Oct 2020

Sponsor / Collaborator

Liaoning He Eye Hospital Group Co., Ltd.

NCT02611778 / CompletedPhase 3

Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration

The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration.

Start Date19 Dec 2015

Sponsor / Collaborator

bioeq GmbH

100 Clinical Results associated with Ranibizumab biosimilar(Formycon AG)

100 Translational Medicine associated with Ranibizumab biosimilar(Formycon AG)

100 Patents (Medical) associated with Ranibizumab biosimilar(Formycon AG)

Literatures (Medical) associated with Ranibizumab biosimilar(Formycon AG)

01 Jun 2023·BMJ open ophthalmology

Systematic review of efficacy and meta-analysis of safety of ranibizumab biosimilars relative to reference ranibizumab anti-VEGF therapy for nAMD treatment

Review

Author: Choudhry, Netan ; Hatamnejad, Amin ; Orr, Samantha ; Dadak, Rohan ; Wykoff, Charles

Topic:

This systematic review and meta-analysis provides a summary of the efficacy and safety of ranibizumab biosimilars relative to reference ranibizumab anti-vascular endothelial growth factor (VEGF) therapy for the treatment of neovascular age-related macular degeneration (nAMD).

Methods:

We conducted systematic searches from January 2003 to August 2022 on Ovid MEDLINE, EMBASE and the Cochrane Controlled Register of Trials. We included studies reporting changes in early treatment diabetic retinopathy study-measured best-corrected visual acuity (BCVA), number of patients who lost or gained more than 15 letters in BCVA from baseline, changes in retinal thickness and adverse events between treatment arms. The following studies were excluded: studies that did not report visual outcomes following biosimilar and reference ranibizumab intravitreal injections, study arms combining anti-VEGF agents with laser or steroid injections, sham injections as a control comparator, studies without English full texts and non-comparative, observational study design.

Results:

Five studies reported on four randomised controlled trials (RCTs) and 1544 eyes at baseline were included in this systematic review and meta-analysis. The studies in our systematic review found no significant differences between reference ranibizumab and ranibizumab biosimilar medications (FYB201, SB11, RanizuRel and Lupin’s ranibizumab) for visual and anatomical outcomes. No significant differences were detected between biosimilar and reference ranibizumab for treatment emergent adverse events (risk ratio, RR 1.06, 95% CI (0.91 to 1.23), p=0.45, I2=52%) or IOP-related adverse events with significant heterogeneity (RR 2.59, 95% CI (0.11 to 62.25), p=0.56, I2=76%).

Conclusion:

This systematic review of four RCTs demonstrated no significant difference in visual outcomes, retinal thickness outcomes, as well as meta-analysis of adverse events between biosimilar and reference ranibizumab therapies for nAMD treatment.

01 Jan 2022·OphthalmologyQ1 · MEDICINE

Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration

Q1 · MEDICINE

Article

Author: Ricci, Federico ; Schmitz-Valckenberg, Steffen ; Kaiser, Peter K ; Holz, Frank G ; Oleksy, Piotr ; Kiefer, Joachim

PURPOSE:

This trial was conducted to investigate the clinical equivalence of the proposed biosimilar FYB201 and reference ranibizumab in patients with treatment-naive, subfoveal choroidal neovascularization caused by neovascular age-related macular degeneration (nAMD).

DESIGN:

This was a prospective, multicenter, evaluation-masked, parallel-group, 48-week, phase III randomized study.

PARTICIPANTS:

A total of 477 patients were randomly assigned to receive FYB201 (n = 238) or reference ranibizumab (n = 239).

METHODS:

Patients received FYB201 or reference ranibizumab 0.5 mg by intravitreal (IVT) injection in the study eye every 4 weeks.

MAIN OUTCOME MEASURES:

The primary end point was change from baseline in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 8 weeks before the third monthly IVT injection. Biosimilarity of FYB201 to its originator was assessed via a 2-sided equivalence test, with an equivalence margin in BCVA of 3 ETDRS letters.

RESULTS:

The BCVA improved in both groups, with a mean improvement of +5.1 (FYB201) and +5.6 (reference ranibizumab) ETDRS letters at week 8. The analysis of covariance (ANCOVA) least squares mean difference for the change from baseline between FYB201 and reference ranibizumab was -0.4 ETDRS letters with a 90% confidence interval (CI) of -1.6 to 0.9. Primary end point was met as the 90% CI was within the predefined equivalence margin. Adverse events were comparable between treatment groups.

CONCLUSIONS:

FYB201 is biosimilar to reference ranibizumab in terms of clinical efficacy and ocular and systemic safety in the treatment of patients with nAMD.

International journal of retina and vitreous

Pipeline therapies for neovascular age related macular degeneration

Review

Author: Arepalli, Sruthi ; Kaiser, Peter K

Abstract:

Age related macular degeneration (AMD) is the most common cause of vision loss in the elderly population. Neovascular AMD comprises 10% of all cases and can lead to devastating visual loss due to choroidal neovascularization (CNV). There are various cytokine pathways involved in the formation and leakage from CNV. Prior treatments have included focal laser therapy, verteporfin (Visudyne, Bausch and Lomb, Rochester, New York) ocular photodynamic therapy, transpupillary thermotherapy, intravitreal steroids and surgical excision of choroidal neovascular membranes. Currently, the major therapies in AMD focus on the VEGF-A pathway, of which the most common are bevacizumab (Avastin; Genentech, San Francisco, California), ranibizumab (Lucentis; Genentech, South San Francisco, California), and aflibercept (Eylea; Regeneron, Tarrytown, New York). Anti-VEGF agents have revolutionized our treatment of wet AMD; however, real world studies have shown limited visual improvement in patients over time, largely due to the large treatment burden. Cheaper alternatives, including ranibizumab biosimilars, include razumab (Intas Pharmaceuticals Ltd., Ahmedabad, India), FYB 201 (Formycon AG, Munich, Germany and Bioeq Gmbh Holzkirchen, Germany), SB-11 (Samsung Bioepsis, Incheon, South Korea), xlucane (Xbrane Biopharma, Solna, Sweden), PF582 (Pfnex, San Diego, California), CHS3551 (Coherus BioSciences, Redwood City, California). Additionally, aflibercept biosimilars under development include FYB203 (Formycon AG, Munich, Germany and Bioeq Gmbh Holzkirchen, Germany), ALT-L9 (Alteogen, Deajeon, South Korea), MYL1710 (Momenta Pharamaceuticals, Cambridge, MA, and Mylan Pharmacueticals, Canonsburg, PA), CHS-2020 (Coherus BioSciences, Redwood City, California). Those in the pipeline of VEGF targets include abicipar pegol (Abicipar; Allergan, Coolock, Dublin), OPT-302 (Opthea; OPTHEA limited; Victoria, Melbourne), conbercept (Lumitin; Chengdu Kanghong Pharmaceutical Group, Chengdu, Sichuan), and KSI-301 (Kodiak Sciences, Palo Alto, CA). There are also combination medications, which target VEGF and PDGF, VEGF and tissue factor, VEGF and Tie-2, which this paper will also discuss in depth. Furthermore, long lasting depots, such as the ranibizumab port delivery system (PDS) (Genentech, San Francisco, CA), as well as others are under evaluation. Gene therapy present possible longer treatments options as well and are reviewed here. This paper will highlight the past approved medications as well as pipeline therapies for neovascular AMD.

News (Medical) associated with Ranibizumab biosimilar(Formycon AG)

30 Oct 2024

·www.globenewswire.com

Sandoz reports third-quarter and nine-month 2024 sales

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Strong third-quarter biosimilars growth of 37% in constant currencies from existing portfolio and recent launchesGenerics growth acceleration driven by EuropeThird-quarter net sales¹ of USD 2.6 billion, up 12% in constant currencies (up 11% in USD)Nine-month net sales of USD 7.6 billion, up 9% in constant currencies (up 8% in USD)Net sales growth guidance increased to high-single digit in constant currencies (from mid- to high-single digit) and core EBITDA margin² guidance of around 20% confirmed Basel, October 30, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced net sales for the third quarter and nine months ended September 30, 2024. For the third quarter, net sales were USD 2.6 billion, an increase of 12% in constant currencies compared to the same quarter of the prior year. For the first nine months of 2024, net sales were USD 7.6 billion, an increase of 9% in constant currencies compared to the prior year. Richard Saynor, Chief Executive Officer of Sandoz, said: “We remain focused on execution, meeting key milestones in our biosimilars business and progressing on our journey as a standalone company. In recent months, we received approval for Pyzchiva® and Enzeevu™ in the US, launched Pyzchiva® in Europe and see continued strong uptake of Hyrimoz® in the US. “Net sales growth was achieved across generics and biosimilars, with generics accelerating in the third quarter and strong double-digit biosimilars growth in both the third quarter and first nine months. Additionally, all three regions contributed to this strong performance. We expect momentum in our business to continue, driving margin expansion through favorable product mix and leveraging our cost base. We have further advanced on our path to simplifying our business, including progression on the transformation program we launched earlier this year.” THIRD-QUARTER AND NINE-MONTH SALES Net sales for the third quarter were USD 2.6 billion, up 12% in constant currencies, compared to the third quarter of 2023. Volume contributed 13 percentage points of growth. This was partially offset by price erosion of 1 percentage point. Biosimilars were the key driver of growth in the quarter, while generics experienced solid demand. Growth accelerated in both businesses. Net sales for the first nine months of 2024 were USD 7.6 billion, up 9% in constant currencies compared to prior year. Volume contributed 11 percentage points of growth. This was partially offset by price erosion of 2 percentage points. The growth was primarily driven by biosimilars, with strong demand for both the base business and new in-market organic and acquired products in the US. Net sales by business Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc* USDcc*Generics 1 8541 794 34 5 5585 512 12Biosimilars 741 543 3637 2 0841 592 3132Net sales to third parties 2 5952 337 1112 7 6427 104 89 *constant currencies Generics overviewNet sales for the third quarter were USD 1.9 billion, up 4% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 5.6 billion, up 2% in constant currencies versus prior year. Growth in the Europe region accelerated in the third quarter, mainly driven by recent launches. The momentum continued in the International region, aided by demand for the antifungal agent Mycamine® and favorable pricing dynamics, partly offset by the divestment of the Chinese business. North America declined due to timing of new launches in the US. Biosimilars overviewNet sales for the third quarter were USD 741 million, up 37% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 2.1 billion, up 32% in constant currencies versus prior year. The strong double-digit biosimilars growth reflects the uptake of Hyrimoz® (adalimumab) in the US, the acquisition of Cimerli® (ranibizumab), the continued strong demand for our first-ever biosimilar, Omnitrope® (somatropin), and the launches of Tyruko® (natalizumab) and Pyzchiva® (ustekinumab) in Europe. Net sales by region Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc USDccEurope 1 3621 204 1312 3 9963 751 76North America 598 510 1718 1 7421 514 1515International 635 623 28 1 9041 839 49Net sales to third parties 2 5952 337 1112 7 6427 104 89 Europe overviewNet sales for the third quarter were USD 1.4 billion, up 12% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 4.0 billion, up 6% in constant currencies versus prior year. Strong growth in biosimilars continues, led by demand for Omnitrope® and the contribution from the recent launches of Tyruko® and Pyzchiva®. Generics momentum accelerated in the third quarter, driven by recent launches and the lapping of the strong prior-year comparison in the first half. North America overviewNet sales for the third quarter were USD 598 million, up 18% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.7 billion, up 15% in constant currencies versus prior year. Growth was driven by the ongoing uptake of Hyrimoz® in the US, the acquisition of Cimerli®, share gain of Omnitrope® in the US and the launch of Wyost®/Jubbonti® in Canada. This was partly offset by a decline in generics sales due to the timing of new launches in the US. International overviewNet sales for the third quarter were USD 635 million, up 8% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.9 billion, up 9% in constant currencies versus prior year. This was primarily a result of strong volume growth across both generics and biosimilars, contribution from the acquisition of Mycamine® in the prior year, favorable price dynamics and recent launches, partly offset by the divestment of the Chinese business in the second quarter. GUIDANCE 2024 On the back of strong momentum in its biosimilars business and solid generics demand, the company is increasing its full-year 2024 net sales guidance to high-single digit growth in constant currencies versus prior year (from mid- to high-single digit) and is confirming its core EBITDA margin guidance of around 20%. THIRD-QUARTER STRATEGIC MILESTONES Sandoz continued to execute on its strategy and passed additional milestones in its biosimilars portfolio. On July 1, the company announced the US FDA approval of biosimilar Pyzchiva® for all indications of the reference medicine. The company intends to launch Pyzchiva® in the US among the first wave of ustekinumab biosimilars in February 2025. On July 25, Sandoz announced the launch of biosimilar Pyzchiva® across Europe to treat chronic inflammatory diseases. Pyzchiva® was the first biosimilar to launch in Europe with all reference medicine strengths, including an initiation dose for Crohn’s disease. On August 12, Sandoz received FDA approval for Enzeevu™ to treat neovascular age-related macular degeneration. This approval further enhances the company’s leading US ophthalmology portfolio and increases access for patients. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential litigation or any potential settlements. KEY LINKS Webcast – Live at 9am CET Analyst call presentationAnalyst consensus 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.This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024. 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. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded net sales of USD 9.6 billion. CONTACTS Global Media Relations contacts Investor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comSteffen Kurzawa+41 79 800 8501Laurent de Weck+41 79 795 7364Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 5217 SUPPORTING FINANCIAL INFORMATION Quarterly net sales 2024 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDccGenerics 1 86901 1 835-11 1 85434Biosimilars 6232121 7203537 7413637Net sales to third parties 2 49256 2 55579 2 5951112 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDcc Europe 1 32642 1 30823 1 3621312North America 52466 6202223 5981718International 642412 62759 63528Net sales to third parties 2 49256 2 55579 2 5951112 2023 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Generics 1 86826 1 85046 1 79454 1 92066Biosimilars 5161117 5331314 54374 6232926Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Europe 1 2701016 1 2771412 1 204113 1 272104North America 496-5-3 508-4-2 510-4-3 6152020International 618-14 598-38 623312 656414Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 ¹ Net sales in this document refer systematically to net sales to third parties. In the first nine months of 2023, third-party sales excluded sales to our former parent. Post spin-off, sales to our former parent are reported as third-party sales.² An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024 Attachment 241030_Q3 and 9M Sales 2024_ Media Release.pdf

Drug ApprovalBiosimilarAcquisition

12 Aug 2024

·pipelinereview.com

Sandoz receives FDA approval for Enzeevu™ (aflibercept-abzv), further strengthening US biosimilar position

BASEL, Switzerland I August 12, 2024 I Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved Enzeevu™ (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. Enzeevu™ is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD).[1] In addition, the FDA provisionally determined Enzeevu™ would be interchangeable with the reference medicine as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products. Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said: “nAMD, or wet AMD, continues to be a leading cause of vision impairment in patients over 50 years in North America. This condition affects millions of people, leading to significant challenges in their daily lives due to the progressive loss of central vision. The US approval of Enzeevu™ is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease.” Enzeevu™ is a key biosimilar value driver for the company and this approval is a major step in advancing the Sandoz growth strategy by further extending its leading US ophthalmology portfolio. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements. nAMD, also known as wet AMD, is a subtype of age-related macular degeneration (AMD), which is a leading cause of vision impairment in patients over 50 years in North America.[2] Jeff Todd, J.D., President and CEO of Prevent Blindness, said: “As sight disappears, so may a person’s connection to the world. We welcome all treatment options that help maintain vision and meet the unique needs of the individual so those living with wet AMD can potentially maintain their independence longer. At this time, there is no cure for this disease and long-term treatment can be costly. Having more FDA-approved options, including biosimilars, can help make healthcare more person-centered and affordable.” The FDA granted approval based on the totality of evidence, including comprehensive analytical and preclinical in vitro study data, as well as clinical data from the Mylight study.[3] This approval follows the acquisition of the Cimerli® (ranibizumab-eqrn) business by Sandoz in the US earlier in 2024. The acquisition, which included field force employees, strengthened the company’s leading ophthalmology portfolio in the US and created a robust platform to support the anticipated launch of Enzeevu™. References [1] Enzeevu™. Prescribing Information. Available at: https://prod.cms.us.sandoz.com/sites/spare37_sandoz_com/files/Media%20Documents/ENZEEVU_PI_2024_2.pdf [Last accessed: August 2024] [2] American Academy of Ophthalmology®. Age-related macular degeneration (AMD). Available at: https://www.aao.org/eye-health/diseases/amd-macular-degeneration [Last accessed: August 2024] [3] Arnaldo B, et al. Efficacy and safety of the proposed biosimilar aflibercept, SDZ-AFL, in patients with neovascular age-related macular degeneration: 52-week results from the Phase 3 Mylight study. Retina. 2024. About Enzeevu™ (aflibercept-abzv) The active ingredient in Enzeevu™ is aflibercept. Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth. In patients with neovascular age-related macular degeneration (nAMD), aflibercept is injected into the eye to improve visual acuity and inhibit disease progression. About Mylight study The Mylight study (NCT04864834) was an international, multicenter, randomized, double-masked, 2-arm parallel study in 485 patients with neovascular age-related macular degeneration (nAMD), with a total duration of 52 weeks.[3] The Mylight study confirmed equivalent efficacy, as well as comparable safety and immunogenicity for Sandoz biosimilar aflibercept and reference medicine Eylea®* (aflibercept) as per Eylea®* approved treatment regimen in patients with nAMD.[3] *Eylea® is a registered trademark of Regeneron Pharmaceuticals, Inc. INDICATIONS Enzeevu™ is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD). IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Ocular or periocular infection Active intraocular inflammation Hypersensitivity WARNINGS AND PRECAUTIONS Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. This is not the complete list of all the safety information for Enzeevu™. Please see full Prescription Info for Enzeevu™ . 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. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded sales of USD 9.6 billion. SOURCE: Sandoz

Clinical ResultDrug ApprovalPhase 3Acquisition

12 Aug 2024

·www.pharmaceutical-technology.com

FDA approves Sandoz’s Enzeevu as Eylea biosimilar saga continues

The biosimilar references Regeneron and Bayer’s blockbuster ophthalmology asset Eylea (aflibercept). Image credit: Shutterstock / photoJS. The US Food and Drug Administration (FDA) has approved Sandoz ’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD). Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer ’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease. Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products. The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release. Interchangeable biosimilars are eligible for a year of market exclusivity if they are the first biosimilar of a given product to receive interchangeable designation, as per the Biologics Price Competition and Innovation Act. It is possible that multiple interchangeable biosimilars could share a period of initial exclusivity if they are approved at the same time. See Also: What’s involved in designing effective lyophilization cycles? Sanofi invests $1.4bn in insulin production in Germany However, how this exclusivity period is exercised was scrutinised when Boehringer Ingelheim , which produces the first interchangeable biosimilar for Humira (adalimumab) called Cyletzo, was in litigation with Pfizer , which also produces an interchangeable biosimilar. The company has said that Enzeevu’s launch will be dependent on the outcome of pending or potential future related litigations, as well as any potential settlements, amongst other factors. Sandoz did not reply to a request from Pharmaceutical Technology to clarify the exclusivity timelines. Biosimilars are not new to the wet AMD treatment space, with the first copycat to Genentech’s Lucentis (ranibizumab) hitting the market in 2021. Sandoz strengthened its ophthalmology portfolio when it spent $170m to acquire Cimerli (ranibizumab-eqrn) – the first interchangeable biosimilar to Lucentis – from Coherus in March this year. Sandoz stated Enzeevu will be a “key biosimilar value driver” as the company expands its ophthalmology presence. Sandoz, which completed its spin-off from Novartis late last year, lifted its 2024 sales guidance earlier this week while reporting Q2 financial results. Propelled by strong sales of the Humira-copycat Hyrimoz, the company notched total sales of $2.6bn for the second quarter. Wet AMD, also known as neovascular AMD, is a leading cause of vision loss, affecting around 1.5 million people aged 40 years and older in the US. Amongst AMD cases, the wet subtype is responsible for 90% of severe vision losses. Similar to Eylea, the biosimilars work by inhibiting vascular endothelial growth factor (VEGF), which prevents abnormal blood vessel growth. Regeneron’s Eylea currently dominates the ophthalmology market, netting $5.89bn in sales last year. However, product revenues were down by 6.3% from the year before due to increased competition from Roche’s wet AMD drug Vabysmo (faricimab) and others. Regeneron has also been locked in various court battles with other companies over alleged patent infringements with their aflibercept biosimilars. Samsung Bioepis’ Opuviz received a preliminary injunction, whilst Biocon was hit with a permanent injunction. Regeneron won a case against Viatris ’s proposed biosimilar in December 2023, citing a patent that protects its drug until 2027. Along with biosimilar introduction, Eylea will also face competition from Vabysmo. Vabysmo, whose patent expires in 2039, reached blockbuster status in only its second year on the market, notching $2.66bn in global sales last year. The biologic is predicted to see revenues of $8.5bn by 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology .

Drug ApprovalBiosimilarPatent Infringement

100 Deals associated with Ranibizumab biosimilar(Formycon AG)

External Link

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Choroidal Neovascularization	US	Sandoz, Inc.	02 Aug 2022
Diabetic macular oedema	US	Sandoz, Inc.	02 Aug 2022
Macular Edema	US	Sandoz, Inc.	02 Aug 2022
Wet age-related macular degeneration	US	Sandoz, Inc.	02 Aug 2022
Dystrophy, Macular	GB	Bioeq AG	17 May 2022
Dystrophy, Macular	GB	Formycon AG	17 May 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PO040 (AAO2021)	Not Applicable	Wet age-related macular degeneration	-	FYB201	uopnxnfznw(vrxqpouixh) = qrmpstirqz ecmqttqtke (wkyyifcomv )	Positive	13 Nov 2021
				refRNB	uopnxnfznw(vrxqpouixh) = onyljshnfp ecmqttqtke (wkyyifcomv )
NCT02611778 (COLUMBUS-AMD, CTgov)	Phase 3	Wet age-related macular degeneration	712	Ranibizumab (FYB201)	zquooxcpbn(ldeytxmlmj) = vurwdqhexa evhycvowia (atcnczexis, seiowsluoa - rqathxpkpq) View more	-	30 Sep 2021
				Ranibizumab (Lucentis)	zquooxcpbn(ldeytxmlmj) = qfebzpbbnx evhycvowia (atcnczexis, jtcaotfaih - aybfidzqdg) View more
PO387 COLUMBUS-AMD (AAO2020)	Not Applicable	Wet age-related macular degeneration	-	FYB201	zsxqesebml(dtzpprovbh) = nkfdawkhbg jilynvnnxx (cqqcgglwge )	Positive	13 Nov 2020
				refRNB	zsxqesebml(dtzpprovbh) = xyewigqzjl jilynvnnxx (cqqcgglwge )

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