The objective of the study is to assess the ocular safety of the FYB201 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.

Start Date11 Jun 2024

Sponsor / Collaborator

Formycon AG

NCT04662944

/ CompletedNot Applicable

A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography (OCT) Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections

RAZORBILL was an observational, multicenter, multinational, open-label, study designed primarily to investigate the influence of automated OCT image enrichment with segmentation information on disease activity assessment in nAMD patients treated with licensed anti-VEGFs

Start Date23 Feb 2021

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT04601675

/ Unknown statusNot Applicable

Randomized Study on Diabetic Macular Edema Patients Receiving Ranibizumab and Dexamethasone or Ranibizumab Only.

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.

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)

12 Dec 2024·Cureus Journal of Medical Science

A Tertiary Centre’s Experience With Using Ranibizumab Biosimilar Compared to Aflibercept for Neovascular Age-Related Macular Degeneration: A Retrospective Study

Article

Author: Al-Bermani, Ayad ; Elahi, Aarij ; Bilal, Ahmed ; Usman, Danyal ; Bilal, Muslim

Objective This study aims to evaluate the real-world efficacy of ranibizumab biosimilar (Ongavia), compared to aflibercept (Eylea), in the treatment of treatment-naïve neovascular age-related macular degeneration (nAMD) at a busy tertiary eye care centre. Methods A retrospective analysis of medical records from August 2022 to August 2024 was conducted, comparing treatment outcomes in treatment-naive nAMD patients who received either Ongavia or Eylea intravitreal anti-VEGF (vascular endothelial growth factor) injections under a treat-and-extend protocol. Initial and 12-month outcome measures post-treatment initiation were collected, including best-corrected visual acuity (BCVA), central retinal thickness (CRT), prescribed treatment intervals, actual injection frequency, and the average total number of injections per eye over 12 months. Results A total of 62 eyes met the inclusion criteria. Over 12 months of follow-up, patients receiving Eylea (n = 36) showed a significantly greater improvement in BCVA (7.08 ± 4.12), p = 0.018, compared to Ongavia (n = 26) (-1.9 ± 3.31). CRT reductions were also more substantial for Eylea (-116.21 µm ± 35.61 µm) than for Ongavia (-51.14 µm ± 22.21 µm), p = 0.002. The average number of injections was 6.55 for Ongavia and 5.75 for Eylea over the 12-month follow-up. Excluding the initial three loading doses, observed injection intervals averaged 9.49 weeks for Eylea and 8.17 weeks for Ongavia. Notably, for the total study period, 164 out of 171 (96%) Ongavia injections were prescribed at four-week intervals, compared to 110 out of 207 (53%) for Eylea. However, capacity constraints impacted adherence to prescribed dosing schedules, affecting efficacy. Conclusion Our study indicates reduced visual and morphological outcomes with Ongavia compared to Eylea in treating nAMD when monthly injections cannot be provided as prescribed. Given clinical capacity constraints, Eylea's greater potency and durability prove advantageous, allowing extended intervals and reducing the reliance on strict monthly dosing. This highlights the need for additional resources to support frequent biosimilar administration and ensure effective ranibizumab treatment. A comprehensive cost-benefit analysis is warranted to assess whether increased clinic capacity offsets Ongavia's lower per-injection cost, compared to Eylea.

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.

121

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

19 May 2025

·www.businesswire.com

FDA Grants Interchangeable Designation to Fresenius Kabi’s biosimilar Otulfi ® (ustekinumab-aauz)

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced today that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab). Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced today that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab). Depending on state pharmacy laws in the U.S., an interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product without requiring direct approval from the prescribing healthcare provider. Not all biosimilars receive interchangeability status. “Fresenius Kabi is pleased to receive this interchangeable designation for Otulfi, and we will continue to evaluate all possibilities in the development and commercialization of our biosimilar portfolio that help create access for patients and healthcare professionals to important, high-quality and affordable therapies,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board. According to recent FDA draft guidance, biosimilar applicants can request an interchangeability designation using existing data from their Biologics License Application (BLA). Previously, the FDA granted this status only to biosimilars that submitted multiple switch studies meeting additional data criteria. This demonstrates that patients who alternated between the reference product and the biosimilar, then returned to the reference product, exhibited no clinically meaningful differences in safety, efficacy, or immunogenicity. This ensures the same clinical outcome for patients treated exclusively with the reference product. About Otulfi Otulfi is indicated for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients; moderate to severely plaque psoriasis for adult patients and pediatric patients six years or older, who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis in adults and pediatric patients six years or older. The development and commercialization of the ustekinumab biosimilar is the first biosimilar product launched in the U.S. from the partnership between Fresenius Kabi and Formycon AG. In February 2023, Fresenius Kabi and Formycon entered a global commercialization partnership for the ustekinumab biosimilar covering key global markets. The drug received FDA approval in September 2024 and has been available in the U.S. since March 2025. Otulfi (ustekinumab-aauz) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, which play an important role in inflammatory and immune responses. The FDA approval of Otulfi (ustekinumab-aauz) was based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. Otulfi demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Stelara® in patients with moderate to severe plaque psoriasis. Otulfi was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S. Otulfi (ustekinumab-aauz) is the fourth Fresenius Kabi biosimilar commercialized in the U.S., following the approvals and launches of adalimumab-aacf, Tyenne® (tocilizumab-aazg) and Stimufend® (pegfilgrastim-fpgk). Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development. Indications Otulfi (ustekinumab-aauz) is an IL-12/23 antagonist indicated for treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis. Otulfi is also indicated for pediatric patients ≥6 years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis. IMPORTANT SAFETY INFORMATION Otulfi (ustekinumab-aauz) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Otulfi (ustekinumab-aauz). Infections Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, urinary tract infections; Psoriatic arthritis: cholecystitis; Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, Listeria meningitis and Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, listeriosis. Avoid initiating treatment with Otulfi (ustekinumab-aauz) in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of Otulfi (ustekinumab-aauz) in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with Otulfi (ustekinumab-aauz). Discontinue Otulfi (ustekinumab-aauz) for serious or clinically significant infections until the infection resolves or is adequately treated. Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), Salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances). Pre-Treatment Evaluation of Tuberculosis (TB) Evaluate patients for TB prior to initiating treatment with Otulfi (ustekinumab-aauz). Avoid administering Otulfi (ustekinumab-aauz) to patients with active TB infection. Initiate treatment of latent TB before administering Otulfi (ustekinumab-aauz). Consider anti-TB therapy prior to initiation of Otulfi (ustekinumab-aauz) in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving Otulfi (ustekinumab-aauz) for signs and symptoms of active TB during and after treatment. Malignancies Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer (NMSC). Monitor all patients receiving Otulfi (ustekinumab-aauz) for the appearance of NMSC. Closely follow patients >60 years of age, those with a medical history of prolonged immunosuppressant therapy, and those with a history PUVA treatment. Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue Otulfi (ustekinumab-aauz). Posterior Reversible Encephalopathy Syndrome (PRES) Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after initiating ustekinumab products. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab. Monitor all patients treated with Otulfi (ustekinumab-aauz) for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue Otulfi (ustekinumab-aauz). Immunizations Prior to initiating therapy with Otulfi (ustekinumab-aauz), patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with Otulfi (ustekinumab-aauz) should not receive live vaccines. Avoid administering BCG vaccines during treatment with Otulfi (ustekinumab-aauz), or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving Otulfi (ustekinumab-aauz) because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of Otulfi (ustekinumab-aauz) may not elicit an immune response sufficient to prevent disease. Noninfectious Pneumonia Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue Otulfi (ustekinumab-aauz) and institute appropriate treatment. Most Common Adverse Reactions The most common adverse reactions (≥3%) seen in patients treated with Otulfi (ustekinumab-aauz) are: Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, fatigue; Crohn’s disease, induction: vomiting; Crohn’s disease, maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis; Ulcerative colitis, induction: nasopharyngitis and Ulcerative colitis, maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, nausea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or to report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please click to see full Prescribing Information and Medication Guide for Otulfi® (ustekinumab-aauz) here. About Formycon Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, have been approved by the FDA, EMA, and MHRA; FYB202 is also approved in Canada. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX and TecDAX selection indices. Further information can be found at: https://www.formycon.com. About Fresenius Kabi As a global health care company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status – notably as the only corporation offering both product groups. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. In keeping with the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of health care. Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing health care solutions on a global scale. For more information, please visit www.fresenius-kabi.com. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook. Otulfi® (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stelara® is a registered trademark of Johnson & Johnson. Tyenne® (tocilizumab-aazg) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stimufend® (pegfilgrastim-fpgk) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.

Drug ApprovalClinical Result

30 Apr 2025

·www.globenewswire.com

Sandoz reports Q1 2025 net sales in line with company expectations; full-year guidance confirmed

Ad-hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Q1 2025 net sales of USD 2,480 million up by 3% in constant currencies (cc); stable in USDup by 5%[1] at a comparable growth rate (CGR), when adjusted for impact of 2024 acquisition of US biosimilar Cimerli® (ranibizumab) and 2024 divestment of China businessten largest-selling medicines grew by combined 4% and represented 33% of net sales Europe net sales grew by 7%[1]. International declined by 2%[1] and increased by 2% when adjusted for China divestment. Net sales in North America grew by 1%[1] and, adjusted for Cimerli acquisition, by 3%Anticipated biosimilar launches primarily weighted to second half of year. Launches include Wyost®/Jubbonti® (denosumab) in Europe and US, Tyruko® (natalizumab) in US[2] and Afqlir® (aflibercept) in EuropeFavorable moves towards regulatory streamlining of biosimilar development reflected in decision to minimize pembrolizumab Phase III trialFull-year impact of US government’s confirmed recent tariffs within guidanceFull-year 2025 guidance confirmed: mid single-digit net-sales growth[1] and core EBITDA margin of around 21% Basel, April 30, 2025 – Sandoz (SIX: SDZ / OTCQX: SDZNY), the global leader in generic and biosimilar medicines, today presents its net-sales update for the first quarter of 2025. Richard Saynor, Chief Executive Officer of Sandoz, commented: “With Q1 sales in line with our expectations, we have now delivered fourteen consecutive quarters of top-line growth. This reconfirms our growing track record of execution and performance, driven by commercial excellence and an expanding biosimilar pipeline and portfolio, underpinned by our generics base. I’m looking forward to additional growth in the second quarter and further progress this year as we launch more biosimilar medicines. “With our business continuing to grow, we are confident of delivering more affordable medicines for patients and savings for society, while producing sustainable growth in sales, profitability and cash generation. It is the powerful combination of delivery and pioneering access for patients that makes us proud to be part of the Sandoz growth journey.” FULL-YEAR 2025 GUIDANCE The Company expects further major biosimilar launches later this year, while price erosion is expected to return to normalised levels of a low to mid-single-digit percentage. Sandoz anticipates core EBITDA-margin expansion to reflect the mix of sales, simplification of the external network and the ongoing transformation program. As a result, the Company continues to expect: FY 2025 net sales to grow by a mid single-digit percentage[3] a core EBITDA margin in FY 2025 of around 21% This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government. FIRST-QUARTER NET SALES Net sales for the first quarter amounted to USD 2,480 million, representing growth of 3%[3]. Volume contributed six percentage points of growth, partly offset by price erosion of three percentage points. Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[3] Generics1,809731,869 -302Biosimilars67127623 81114Net Sales2,4801002,492 035 Generics overviewNet sales for the first quarter were USD 1,809 million, reflecting a stable performance[3] (+2% on a CGR basis). Generics represented 73% of total net sales (Q1 2024: 75%). Europe sales of generics grew in the first quarter, driven by the effect of launches in 2024. International net sales declined, with the impact from the divested China business outweighing growth in other markets. In North America, generics’ net-sales growth benefitted from the successful recent launch of paclitaxel. Biosimilars overviewNet sales for the first quarter were USD 671 million, reflecting growth of 11%[3] (+14% on a CGR basis). Biosimilars represented 27% of total net sales (Q1 2024: 25%). Strong Europe biosimilars’ net-sales growth benefitted from a number of good performances, including Hyrimoz® (adalimumab) and recently launched Pyzchiva® (ustekinumab), while International biosimilar net sales also saw a strong contribution from Omnitrope® (somatropin). North America biosimilar net sales declined, reflecting the withdrawal of Cimerli during the quarter; excluding the impact of the 2024 acquisition Cimerli, North America biosimilar net sales increased. Net sales by region Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[4] Europe1,372551,326 377International59024642 -8-22North America51821524 -113Net Sales2,4801002,492 035 Europe overviewNet sales for the first quarter amounted to USD 1,372 million, reflecting growth of 7%[4]. Europe net sales of generics grew in the first quarter, with higher growth in biosimilars primarily a result of recent launches, including Pyzchiva. International overviewNet sales for the first quarter amounted to USD 590 million, reflecting a decline of 2%[4]. Excluding the impact of the divestment of the China business, growth amounted to 2%[4]. Pricing increased in both generics and biosimilars during the quarter, with strong biosimilar net sales partly a result of the continued good performance from Omnitrope. North America overviewNet sales for the first quarter amounted to USD 518 million, reflecting growth of 1%[4]. Excluding the impact of the withdrawal of Cimerli, growth amounted to 3%[4]. A good performance from generics was driven by the successful recent launch of paclitaxel, as well as continued strong growth in Canada. Biosimilar net-sales growth would have been positive when excluding the impact of the 2024 acquisition of Cimerli. Price erosion was driven by reduced Cimerli and private-label adalimumab pricing. US TARIFFS The only tariffs applicable to the Company, as part of recent implementation from the US government, is a total 20% China tariff, implemented on March 4, 2025, and a tariff on any medicines coming from Canada but outside the scope of the United States-Mexico-Canada Agreement. These impacts have been incorporated within full-year guidance. The Sandoz manufacturing footprint consists of 15 sites, including 11 in Europe and one in the US, from which the latter does not export to Europe. US first-quarter net sales represented less than one-fifth of total net Q1 sales. REGULATORY STREAMLINING: BIOSIMILARS Reflecting encouraging and favourable developments, Sandoz has decided to minimize its ongoing Phase III trial in patients with untreated metastatic non-squamous non-small cell lung cancer for the proposed biosimilar, pembrolizumab. The ongoing Phase I pharmacokinetic trial is continuing as planned. This decision was partly based on communications with the US FDA, as well as a reflection paper published by the European Medicines Agency. The Company is assessing implications, including for its wider biosimilars pipeline. In April 2025, Sandoz announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of Enbrel®[5] (etanercept), first approved by the US FDA in 1998. Sandoz alleges that Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi®[6] (etanercept-szzs), by unlawfully purchasing and using certain patent rights to entrench its position in the market. KEY LINKS A conference call and webcast for investors and analysts will begin today at 9am CET. Details can be found here, with the accompanying presentation here. CALENDAR The Company intends to publish its half-year results on August 7, 2025. [1] In constant currencies (cc).[2] Subject to FDA approval of John Cunningham virus assay.[3] In constant currencies (cc).[4] In constant currencies (cc).[5] Enbrel® is a registered trademark of Amgen, Inc.[6] Erelzi® is a registered trademark of Sandoz, Inc. CONTACTS Media Relations contactsInvestor Relations contactsglobal.mediarelations@sandoz.cominvestor.relations@sandoz.comAlex Kalomparis+41 79 279 02 85Craig Marks+44 7818 942 383Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 52 17Danja Spring+41 79 156 74 88Rupreet Sandhu+41 79 410 54 72 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 latest Integrated Annual Report. 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 more than 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 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 2024, Sandoz recorded net sales of USD 10.4 billion. APPENDIX QUARTERLY NET SALES The Company intends to provide the net-sales performance by region by generics/biosimilars at each half-year and full-year results. FY 2024 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccGenerics 1,86901 1,835-11 1,85434 1,94614Biosimilars6232121 7203537 7413637 7692325Net Sales 2,49256 2,55579 2,5951112 2,71579 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccEurope 1,32642 1,30823 1,3621312 1,36778International642412 62759 63528 65306North America52466 6202223 5981718 6951314Net Sales 2,49256 2,55579 2,5951112 2,71579 Attachment Media release_Q1 2025 sales.pdf

BiosimilarDrug ApprovalPhase 3Phase 1Acquisition

05 Mar 2025

·www.pharmaceutical-technology.com

Sandoz said it expects net sales to grow by a mid-single digit percentage in constant currencies in 2025. Image credit: Shutterstock/ T. Schneider. Sandoz reported a 9% growth in net sales of generics and biosimilars to third parties for 2024, marking a strong first financial year as an independent company. After completing its spin-off from Novartis in October 2023, Sandoz has been busy launching new products and simplifying its business. Whilst generics made up the bulk of the Swiss company’s $10.4bn in net sales in 2024, biosimilars pushed more of the growth. Generics brought in $7.5bn for growth at constant exchange rates of 2%, whereas biosimilar sales grew 30% to bring in $2.8bn. Investor reaction to the earnings suggested that performance was in line with expectations. Shares in the company opened almost 1% higher following the announcement. Sandoz has a market cap of $19.2bn. Sandoz’s earnings report come at a time when geopolitical events have significantly impacted market fluctuations. The company issued a guidance on the potential fallout from trade tariffs imposed by the US government on Canada, Mexico, and China. Levies on imported goods could negatively impact the biopharma industry such as raising drug prices and worsening shortages. “The US accounts for just under 20% of our global revenues, as we are a European-based company with strong growth potential in the US, but not dependent on any one market. Potential tariffs on imports from China and Canada are included in our 2025 guidance. For Europe, it is still too early to model,” Sandoz CEO Richard Saynor said in a statement to Pharmaceutical Technology . Sandoz pointed to the uptake of its Humira biosimilar Hyrimoz in the US through a private-label agreement with CVS biosimilar subsidiary Cordavis as one of the drivers of its biosimilar business growth. Humira, AbbVie’s mega blockbuster, was once the world’s bestselling drug, bringing in revenue of $21.2bn in 2022, and the launch of several biosimilars has represented a sizeable loss-of-exclusivity value. Along with autoimmune diseases, Sandoz has been active in the ophthalmologic space. The US Food and Drug Administration (FDA) approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD), in August 2024. Despite battling for AMD market share against products from rivals Biocon Biologics and Samsung Bioepis, Sandoz consolidated its position in March 2024 with a $170m acquisition of Cimerli (ranibizumab-eqrn), a biosimilar approved for a range of retinal diseases. In its generics business, price erosion led to a decline in US sales, the company said. Sandoz also cited the divestment of its China operations as an offset to international growth. South Africa-based Aspen Pharmaceuticals bought Sandoz’s Chinese business for $100m at the tail-end of 2023. 2025 outlook During the call, Sandoz highlighted several strategic business decisions, including a reduction in the number of its internal manufacturing sites to 15, down from 18 in 2023. The company boosted the capacity at remaining sites and consolidated the number of its external suppliers. Saynor told Pharmaceutical Technology : “This allows us to simplify our supply chain and optimise capacity usage and processes. Ultimately, it helps us to secure supply, stabilise our cost basis, and increase patient access to critical medicines worldwide.” Looking ahead to 2025, Sandoz said it expects net sales to grow by a mid-single digit percentage in constant currencies. Sandoz has already launched Stelara biosimilar Pyzchiva (ustekinumab-ttwe) in the US and has eyes on launching the Tysabri biosimilar Tyruko in the country in 2025 too. Whilst experiencing significant growth, the biosimilar market has been saturated with lawsuits. Johnson & Johnson (J&J) recently, for example, sued Samsung Bioepis over a breach of contract for Stelara. Nevertheless, GlobalData forecasts biosimilar sales to increase from 5.7% in 2022 to 18.3% in 2032 through the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and China). GlobalData is the parent company of Pharmaceutical Technology.

AcquisitionDrug ApprovalBiosimilarPatent Expiration

100 Deals associated with Ranibizumab biosimilar(Formycon AG)

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Approved

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

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Vision, Low	Phase 3	China	Novartis Pharmaceuticals Corp.	05 Nov 2014

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FORCE Study (EURETINA2024)	Not Applicable	-	1,230	Ranibizumab biosimilar (FYB 201) 0.5 mg	tgtvcxvhpo(wklegwvoct) = ebwkvxqukd jcpyysjhcv (odsqxmzgqp ) View more	Positive	19 Sep 2024
EURETINA2023	Not Applicable	Retinal Vein Occlusion	-	Aflibercept (Eylea)	bqunqryqee(nxaacotxkb) = lmwunwhgvw vezynjotfm (lxoruvqqyx )	-	05 Oct 2023
				Reference Ranibizumab (Lucentis)	bqunqryqee(nxaacotxkb) = sngzkirhbc vezynjotfm (lxoruvqqyx )
PO040 (AAO2021)	Not Applicable	Wet age-related macular degeneration	-	FYB201	thovyazccn(piodiobsjx) = vqrxrewtel janndcljyf (vqvrfkczzt )	Positive	13 Nov 2021
				refRNB	thovyazccn(piodiobsjx) = bcajgueeaj janndcljyf (vqvrfkczzt )
NCT02611778 (COLUMBUS-AMD, CTgov)	Phase 3	Wet age-related macular degeneration	712	ranibizumab (FYB201)	zyafpqmtol(auewnzkcnz) = fppdfeuwrv tgsgtnzoge (jgdvvdqoid, 7.52) View more	-	30 Sep 2021
				ranibizumab (Lucentis)	zyafpqmtol(auewnzkcnz) = jiprxsbucv tgsgtnzoge (jgdvvdqoid, 8.63) View more
PO387 COLUMBUS-AMD (AAO2020)	Not Applicable	Wet age-related macular degeneration	-	FYB201	ajwgzrafje(pdphiicosl) = gychxukict jwzyogktin (bodhvntbiv )	Positive	13 Nov 2020
				refRNB	ajwgzrafje(pdphiicosl) = aowmhwzjtm jwzyogktin (bodhvntbiv )
NCT02259088 (REFINE, CTgov)	Phase 3	Diabetic macular oedema \| Vision, Low	384	Sham laser+Ranibizumab+RFB002 (Ranibizumab (RFB002))	pjawyrfilg(gniqqulsfs) = eboxpandsx ulrxnerlbf (wzbcvuvcem, 6.58) View more	-	01 Feb 2019
				Laser (Laser)	pjawyrfilg(gniqqulsfs) = dtjkpyajro ulrxnerlbf (wzbcvuvcem, 7.73) View more
NCT01535261 (CRYSTAL, CTgov)	Phase 3	Retinal Vein Occlusion \| Macular Edema \| Vision, Low	357	Ranibizumab 0.5 mg/0.05 ml	rqxainuyka(opmnikcmmh) = sjevnhrafc eruhxvkadr (dzingbqikj, 16.72) View more	-	03 Jun 2016
NCT00284050 (RESOLVE, CTgov)	Phase 2	Diabetic macular oedema	151	Ranibizumab 0.3 mg (Ranibizumab 0.3 mg)	gwcafdocfw(dnpdcaeqhx) = llsdrkblzt riurclrbtl (ferufmaggq, 5.60) View more	-	20 Jan 2011
				Ranibizumab 0.5 mg (Ranibizumab 0.5 mg)	gwcafdocfw(dnpdcaeqhx) = ebxcgfrcub riurclrbtl (ferufmaggq, 9.21) View more

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