Cimerli (ranibizumab-eqrn) / Amneal, Formycon, Coherus Oncology, Teva, Bio Usawa, Bioeq AG, Zydus Lifesci - LARVOL DELTA

Efficacy and safety of switching from Eylea® and Lucentis® to Ranivisio® in exudative age-related macular degeneration and its impact on treatment costs (PubMed, J Fr Ophtalmol) - "Switching from Eylea® and Lucentis® to Ranivisio® is effective in exudative AMD, with a good safety profile, and could help to reduce treatment costs."

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

U.S. trends of anti-vascular endothelial growth factor use from 2017-2023: An analysis of medicare, medicaid, and commercial insurance. (PubMed, PLoS One) - "Aflibercept 2 mg was the most common drug used overall from 2017-2023. Faricimab had the highest absolute and relative increase in utilization from 2022-2023. Patients with Medicare B or C were significantly more likely to receive aflibercept over bevacizumab."

Journal • Medicare • Reimbursement • Retrospective data • US reimbursement • Ophthalmology

Bio Usawa Receives Ghana FDA Approval for BioUcenta (The Manila Times) - "This approval follows closely on the heels of authorization by the Rwanda FDA, underscoring growing regulatory momentum for biosimilars across Africa and paving the way for broader regional access to life-saving biologic therapies...The Ghana FDA’s approval was granted following a rigorous, science-based regulatory review that referenced comprehensive data previously evaluated and accepted by the European Medicines Agency (EMA)...Final pricing for BioUcenta has not yet been announced, but Bio Usawa expects it to be offered at a significantly lower price than the originator."

Approval • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy

Zydus Partners with Bioeq for U.S. Commercialisation rights for NUFYMCO, an Interchangeable Biosimilar to Lucentis (PRNewswire) - "The Biologics License Application (BLA) for NUFYMCO has been approved by U.S. Food and Drug Administration (USFDA) on December 18, 2025....Under the terms of this agreement, Bioeq will be responsible for the development, manufacturing, registration and supply of the finished product, while Zydus will be responsible for the commercialisation of NUFYMCO in the U.S. market."

FDA approval • Licensing / partnership • Diabetic Macular Edema • Diabetic Retinopathy • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Group revenues and earnings development on track – guidance for 2025 confirmed (Formycon Press Release) - "Revenues from the ranibizumab biosimilar FYB201 from direct participation in commercialization proceeds amounted to €1.5 million (9M/2024: €6.0 million)...Revenues from direct participation in the commercialization of FYB202 amounted to €3.2 million (9M/2024: €0)."

Sales • Crohn's disease • Diabetic Macular Edema • Immunology • Psoriatic Arthritis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Sandoz delivers a further acceleration in sales growth; full-year margin guidance upgraded (Sandoz Press Release) - "All regions in growth at CC in both periods. Europe 9M net sales grew by 6% at CC, while International was up by 4% at CC (by 6% when adjusted2 for 2024 China divestment). North America grew by 1% at CC (by 7% when adjusted2 for Cimerli acquisition)."

Commercial • Wet Age-related Macular Degeneration

Formycon’s FYB201/Ranivisio sets innovative standard as Europe’s First Ranibizumab Biosimilar available in Pre-filled Syringe (Formycon Press Release) - "The launch started in France in October 2025, with additional countries – including Germany – to follow in a staggered approach....The ready-to-use syringe reduces preparation time and supports efficient administration for patients with neovascular (wet) age-related macular degeneration (nAMD) and other serious retinal diseases."

Biosimilar launch • Diabetic Macular Edema • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

FYB-201 Biosimilar ranibizumab (Ongavia/Ranivisio/Cimerli) Efficacy and Safety in Clinical Settings - FORCE study. (PubMed, Eye (Lond)) - "Ranibizumab biosimilar (FYB 201) injections were effective and safe in this real-world experience, with stable visual acuity and reduced CFT with no major complications."

Journal • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Cost-effectiveness of anti-vascular endothelial growth factor and macular laser treatments for people with centre-involving diabetic macular oedema and central retinal thickness of at least 400 micrometres. (PubMed, Eye (Lond)) - "Given their clinical and cost-effectiveness at confidential prices, NICE recommends offering a licensed cost-effective anti-VEGF as first-line treatment for people with CI-DMO and CRT ≥ 400 µm. The use of bevacizumab for this population is not licensed in the UK and would be considered off-label."

HEOR • Journal • Diabetic Macular Edema • Macular Edema • Ophthalmology

Efficacy of Switching to Biosimilar Ranibizumab in Eyes Initially Treated with Reference Ranibizumab for Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, or Retinal Vein Occlusion. (PubMed, Curr Eye Res) - "Mean injection interval increased from 8.3 weeks to 8.9 weeks in the ranibizumab vs. the ranibizumab-eqrn groups for all indications (p < 0.01). In this large real-world study, eyes with nAMD, RVO, and DME switched to ranibizumab-eqrn from reference ranibizumab demonstrated similar efficacy."

Journal • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Bio Usawa becomes partner for the commercialization of FYB201/BioUcenta (ranibizumab) across Sub-Saharan Africa (Formycon Press Release) - "Product launch expected in Q1/2026 in the first countries...Formycon AG...announces that Bioeq AG ('Bioeq'), licensee and exclusive holder of the worldwide commercialization rights for FYB201, Formycon’s biosimilar candidate for Lucentis (ranibizumab), entered into an exclusive partnership with African biotechnology company Bio Usawa Biotechnology Ltd...This partnership grants Bio Usawa exclusive rights to register and commercialize FYB201 under the brand name BioUcenta, bringing a highly effective ophthalmic medicine within reach for millions of patients across Sub-Saharan Africa....FYB201/ BioUcenta is a monoclonal antibody used to treat diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), and other retinal diseases like diabetic retinopathy..."

Biosimilar launch • Licensing / partnership • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Neuropathy • Retinal Disorders

Lucentis biosimilar FYB201/Ranivisio (ranibizumab) approved in Brazil (Formycon Press Release) - "Formycon AG...announces that the Brazilian regulatory authority ANVISA has granted marketing authorization for Ranivisio, a biosimilar to Lucentis (ranibizumab). Product launch by the Brazilian biopharma specialist Biomm is expected in Q4 2025, marking the beginning of a phased market rollout of FYB201/Raniviso across Latin America....Further approvals and product launches in Central and South America are planned through early 2027."

Approval • Launch non-US • Launch US • Macular Degeneration • Wet Age-related Macular Degeneration

Group revenue and EBITDA in line with expectations – FYB202 revenue contributions reflect a successful market launch (Firstwordpharma Press Release) - "Formycon Group generated revenues of €5.3 million in Q1 2025 (Q1/2024: €17.7 million). The year-on-year decline was anticipated and reflects the revenue mix shift. In the prior-year period, significant milestone revenues were recognized from the commercialization partnership with Fresenius Kabi related to the FYB202 project.As development of the pre-filled syringe for the two ophthalmic biosimilars FYB201 and FYB203 progressed successfully, revenues from reimbursed development services declined as expected accordingly...Despite being on the market for only about one month in the U.S. and Europe, FYB202/Otulfi generated revenues of €0.74 million in the first quarter, demonstrating a positive market launch. Further increasing revenue contributions are expected over the course of the year, positioning FYB202 as a key revenue driver for the Group in 2025...As expected, revenues from the ranibizumab biosimilar FYB201 were below the prior-year..."

Commercial • Crohn's disease • Diabetic Macular Edema • Inflammatory Bowel Disease • Macular Degeneration • Psoriasis • Ulcerative Colitis

Solid business development and market performance in fiscal year 2024 (Formycon Press Release) - "Group revenues in financial year 2024 amounted to €69.7 million, which is above the communicated forecast (€55.0 million to €65.0 million). Compared to the previous year, this represents an anticipated decrease of 10.3% (previous year: €77.7 million). The change is mainly due to the decline in deferred milestone revenues for the FYB202 project from the partnership with Fresenius Kabi. These amounted to €23.1 million in the financial year (previous year: €37.7 million). In addition, revenues from the reimbursement of development activities for FYB201 and FYB203 decreased as expected. On the opposite, one-time proceeds from the sale of excess inventory from the FYB202 development, realized in the amount of €9.5 million, had a positive effect."

Commercial • Age-related Macular Degeneration • Crohn's disease • Diabetic Macular Edema • Immunology • Psoriasis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Formycon...provides update on potential need to adjust the valuation of FYB202 and FYB201 (Formycon Press Release) - "In coordination with commercialization partner Fresenius Kabi AG, as part of the imminent market launch of FYB202/Otulfi in the U.S., Formycon anticipates that the valuation model and balance sheet measurement for FYB202 will need to be reviewed and adjusted due to an emerging, significantly higher-than-expected price discount for biosimilars. Based on preliminary calculations, Formycon currently expects a non-cash impairment requirement in the high double-digit to low triple-digit million range....Due to the increasing price discounts among ranibizumab providers in the U.S., Bioeq AG, the exclusive license holder of FYB201/CIMERLI, is currently in discussions with its commercialization partner Sandoz AG regarding the future commercialization strategy for FYB201/CIMERLI in the U.S. Based on the status of these discussions, Formycon currently expects that the commercialization of FYB201/CIMERLI will likely be temporarily paused."

Commercial • Age-related Macular Degeneration • Crohn's disease • Inflammatory Bowel Disease • Psoriatic Arthritis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Drugs for age-related macular degeneration. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Ocular Safety and Usability Study for FYB201 PFS (clinicaltrials.gov) - P4 | N=31 | Completed | Sponsor: Formycon AG

New P4 trial • Age-related Macular Degeneration • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

Sandoz reports third-quarter and nine-month 2024 sales (GlobeNewswire) - "Net 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)..."

Commercial • Age-related Macular Degeneration • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ophthalmology • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Sandoz reports second-quarter sales and half-year 2024 results (GlobeNewswire) - "In recent months, we saw strong uptake of Hyrimoz in the US, received approval for Pyzchiva (ustekinumab) and Wyost/Jubbonti (denosumab) in the US and Europe and secured a settlement agreement in the US with launch dates in the first half of 2025....Total cash and cash equivalents decreased to USD 0.7 billion on June 30, 2024, compared to USD 1.1 billion on December 31, 2023. Net cash flows from operating activities were more than offset by our first dividend payment of USD 215 million and the Cimerli acquisition of USD 188 million."

Biosimilar launch • Commercial • Age-related Macular Degeneration • Crohn's disease • Immunology • Inflammatory Bowel Disease • Macular Degeneration • Ophthalmology • Osteoporosis • Psoriasis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Sandoz reports first quarter 2024 sales (Sandoz Press Release) - "Net sales for the first quarter were USD 623 million, up 21% in constant currencies, compared to the first quarter of 2023. This strong double-digit biosimilar growth reflects the ongoing launch of Hyrimoz high-concentration formulation, the acquisition of CIMERLI as well as continued strong demand for our first-ever biosimilar, Omnitrope."

Commercial • Age-related Macular Degeneration • Crohn's disease • Immunology • Inflammatory Bowel Disease • Macular Degeneration • Ophthalmology • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Trends in Anti-VEGF Intravitreal Injections over 4 Years in a Large Retinal Practice (ARVO 2024) - "Anti-VEGF IVIs utilized were aflibercept (ALF) bevacizumab (BEVA), faricimab-svoa (FAR), ranibizumab 0.5 milligrams (mg) (RAN 0.5), ranibizumab 0.3 mg (RAN 0.3) ranibizumab-eqrn (RANe), ranibizumab-nuna (RANn) and brolucizumab (BROL)... Approved for treatment of diabetic retinopathy in May 2019, ALF has become the most used anti-VEGF IVI. ALF displayed an 85% increase in usage from 2019-2020, it steadily rose after. BEVA, the only off label anti-VEGF, usage percentage dropped over the 5 years."

Diabetic Retinopathy • Ophthalmology • Retinal Disorders

CONVINCING OVERALL PERFORMANCE – FORMYCON REPORTS PRELIMINARY RESULTS FOR THE FINANCIAL YEAR 2023 AND EXCEEDS FORECAST (Formycon Press Release) - "The marketing of the ranibizumab biosimilar FYB201, which is now available in a total of 17 countries worldwide, also contributed to an increase in revenue and net earnings contributions. Revenue resulting from direct participation in the marketing of the Lucentis biosimilar FYB201 amounted to around € 4.1 million....For 2024, the Formycon Group expects sales revenue of between € 55 million and € 65 million. This will mainly result from sales contributions from the marketing proceeds of FYB201, which will be launched in additional countries and regions in 2024. In addition, there is expected revenue from development services for the out-licensed and partnered projects FYB203 and FYB201, which are lower than in previous years due to the advanced stage of the projects."

Biosimilar launch • Commercial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

FORMYCON ANNOUNCES COMMERCIAL LAUNCH OF FYB201 (RANIBIZUMAB) IN CANADA (RANOPTOTM) AND SWITZERLAND (RANIVISIO) (Formycon Press Release) - "Formycon AG...and Bioeq AG announce the commercial launch of FYB201, a biosimilar to Lucentis (Ranibizumab), in Canada and Switzerland. The launch follows the marketing authorization granted by Health Canada under the trademark RanoptoTM and Swissmedic under the trademark Ranivisio."

Biosimilar launch • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Coherus BioSciences Reports Fourth Quarter, Full Year 2023 Financial Results and Provides Current Business Update (GlobeNewswire) - "CIMERLI net sales of $52.4 million in the fourth quarter and $125.4 million in FY 2023....Net revenue was $91.5 million during the three months ended December 31, 2023 and included $36.2 million of net sales of UDENYCA, $52.4 million of net sales of CIMERLI, $2.2 million of net sales of YUSIMRY which was launched in July 2023 and $0.6 million of net sales of LOQTORZI which began shipping to distributors in December 2023 in preparation for launch."

Sales • Age-related Macular Degeneration • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ophthalmology • Ulcerative Colitis • Wet Age-related Macular Degeneration

Sandoz acquires CIMERLI business from Coherus, further building biosimilar and ophthalmology leadership in US market (GlobeNewswire) - "Sandoz...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....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."

M&A • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration