Cimerli (ranibizumab-eqrn) / Amneal, Formycon, Coherus Oncology, Teva - LARVOL DELTA

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

Sandoz announces agreement to acquire CIMERLI business from Coherus, strengthening position in US market (Sandoz Press Release) - "Sandoz...has signed an agreement to acquire the US biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. for an upfront cash purchase payment of USD 170 million. This is inclusive of a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software....Closing is anticipated in 1H 2024, subject to standard conditions and approvals."

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

Health Canada approves FYB201/Ranopto (Ranibizumab), a biosimilar to Lucentis (PharmiWeb) - "Formycon AG, Polpharma Biologics Group BV, Bioeq AG and Teva Canada Ltd. jointly announce that Health Canada has granted the 'Notice of Compliance' (NOC) for Ranopto® (Ranibizumab), a biosimilar to Lucentis®, for the treatment of several serious retinal diseases in Canada."

Canadian regulatory • Age-related Macular Degeneration • Diabetic Macular Edema • Ophthalmology • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Formycon publishes nine-month results for 2023 (PharmiWeb) - "For 2023, the Formycon Group continues to expect revenues of between € 75.0 million and € 85.0 million, which will mainly result from marketing proceeds from the Lucentis biosimilar (FYB201) Ranivisio/ Ongavia /CIMERLI and success payments for the FYB202 project as well as from development services for the out-licensed FYB203 project and the FYB201 project developed in partnership. The forecast for key operating figures such as EBITDA is also expected to remain in the range of € -5.0 million to € -15.0 million due to further R&D investments in the product pipeline."

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

Coherus BioSciences Reports Third Quarter 2023 Financial Results and Business Highlights (Yahoo Finance) - "CIMERLI (ranibizumab-eqrn) net product sales increased in the third quarter 2023 to $40.0 million compared to $26.7 million in the second quarter. CIMERLI sales have exceeded 100,000 doses since commercial launch on October 3, 2022, and CIMERLI held a 29% share of the overall ranibizumab market in the third quarter 2023....Net revenue was $74.6 million during the three months ended September 30, 2023 and included $33.0 million of net sales of UDENYCA, $40.0 million of net sales of CIMERLI..."

Commercial • Sales • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

CIMERLI (ranibizumab-eqrn) Sales Exceed 100,000 Doses in First Year of Launch (Yahoo Finance) - "Coherus BioSciences, Inc...announced that sales of CIMERLI® (ranibizumab-eqrn) to retinal specialists have exceeded 100,000 doses since commercial launch on October 3, 2022. CIMERLI® is the first and only FDA-approved biosimilar interchangeable with Lucentis® for all approved indications. In August 2023, CIMERLI® achieved 25% market share of the ranibizumab market, making it the #1 ranibizumab biosimilar....Coherus plans to report CIMERLI® net sales for the third quarter when the company reports Q3 2023 financial results in November."

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

VIDEO: Efficacy, safety of biosimilars discussed at ASRS annual meeting (Healio) - "...Esther M. Bowie, MD, discusses findings presented at the ASRS annual meeting on the efficacy and safety of ranibizumab biosimilars. The study, which evaluated 3,964 patients, was presented by Carl C. Awh, MD, FASRS....In addition, Bowie discussed phase 3 findings presented by Min Sagong, MD, PhD, on SB15, an aflibercept biosimilar, after 1 year of treatment in patients with neovascular age-related macular degeneration."

Clinical data • P3 data • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Formycon Reports Successful First Half Of 2023 (MENAFN news) - "Due to the highly fragmented EU market, country-level product launches of FYB201 will take place sequentially through the end of 2023, with further launches in countries such as Brazil, Canada and Saudi Arabia planned in 2024."

Launch Canada • Launch non-US • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Coherus BioSciences Reports Second Quarter 2023 Financial Results and Business Highlights (Yahoo Finance) - "CIMERLI® (ranibizumab-eqrn) net product sales more than quadrupled to $26.7 million compared to the prior quarter following the April 1, 2023 implementation of the permanent, product-specific Q-code....Coherus expects its 2023 net product revenue will exceed $275 million, including at least $100 million of CIMERLI® net revenue."

Sales • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Systematic review of efficacy and meta-analysis of safety of ranibizumab biosimilars relative to reference ranibizumab anti-VEGF therapy for nAMD treatment. (PubMed, BMJ Open Ophthalmol) - "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."

Journal • Retrospective data • Review • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Efficacy and Safety of Biosimilar Ranibizumab-nuna and Ranibizumabeqrn in Clnical Use by a Consortium of Retina Specialists (ASRS 2023) - No abstract available

Clinical

Coherus BioSciences Reports First Quarter 2023 Financial Results and Business Highlights (Yahoo Finance) - "Net revenue was $32.4 million during the three months ended March 31, 2023 and included $26.2 million of net sales of UDENYCA and $6.2 million of net sales of CIMERLI®, which was launched in October 2022....Coherus expects its 2023 net product revenue will exceed $275 million, including at least $100 million of CIMERLI® net revenue."

Commercial • Sales • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration