Otulfi (ustekinumab-aauz) / Formycon, Fresenius Kabi - LARVOL DELTA

CMS Grants Fresenius Kabi Permanent, Product-Specific Q-Code for Otulfi (ustekinumab-aauz) (Businesswire) - "Measures will streamline claims, reimbursement effective April 2025...Fresenius Kabi, an operating company of Fresenius, announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent, product-specific billing code for Otulfi (ustekinumab-aauz)...Under the Healthcare Common Procedure Coding System (HCPCS), the Q-code Q9999 is for 'Injection, for subcutaneous use or intravenous use, ustekinumab-aauz (Otulfi), biosimilar per 1.0 mg.'....Otulfi (ustekinumab-aauz) is FDA-approved for subcutaneous and intravenous formulations to treat the same conditions as the reference product Stelara (ustekinumab), including Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis."

US reimbursement • Crohn's disease • Psoriasis • Psoriatic Arthritis • 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

FYB202/Otulfi (ustekinumab-aauz), a biosimilar to Stelara, launched in…the European Union (Formycon Press Release) - "Formycon AG...and its commercialization partner Fresenius announce the commercial availability of Otulfi, a biosimilar to Stelara in...the European Union (EU)...In the EU, Otulfi has been launched to treat moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis....Otulfi in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA and EMA approval in the first half of 2025."

Biosimilar launch • EMA approval • FDA approval • Crohn's disease • Psoriasis • Psoriatic Arthritis

A Randomised, Double-Blind Trial to Compare the Efficacy, Safety, and Immunogenicity of the Biosimilar Ustekinumab FYB202 with Reference Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis. (PubMed, Adv Ther) - P3 | "FYB202 demonstrated therapeutic equivalence to reference ustekinumab in patients with moderate-to-severe plaque psoriasis."

Journal • Dermatology • Immunology • Psoriasis

Fresenius Continues Growth of Biosimilars Portfolio with the U.S. Availability of Otulfi (ustekinumab-aauz) (Businesswire) - "Fresenius Kabi...announced today that the ustekinumab biosimilar Otulfi (ustekinumab-aauz) developed by Formycon AG, is now available in the United States. Otulfi is an ustekinumab biosimilar for the reference product Stelara (ustekinumab). 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."

Biosimilar launch • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

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

The totality of evidence for FYB202 – an EU-approved and US-licensed biosimilar to reference ustekinumab (ECCO-IBD 2025) - "Based on a totality of evidence approach, proof of therapeutic equivalence in the sensitive psoriasis population allows for extrapolation to other indications, with similar clinical performance of FYB202 and reference ustekinumab assumed across all approved indications. FYB202 provides a safe and effective biosimilar alternative for patients in need of ustekinumab therapy."

Inflammatory Bowel Disease • IL12A • IL23A

Formycon and Fresenius Kabi announce MHRA approval for FYB202/Otulfi (ustekinumab), a biosimilar to Stelara (Formycon Press Release) - "Formycon AG...and its commercialization partner Fresenius Kabi announce that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi (ustekinumab), a biosimilar to Stelara, for the treatment of moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis....The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis)."

MHRA approval • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Fresenius Kabi Canada has received a Health Canada Notice of Compliance (NOC) for Otulfi an Ustekinumab Biosimilar (Canada Newswire) - "Fresenius Kabi Canada proudly announces the recent Health Canada Notice of Compliance (NOC) for Otulfi, an ustekinumab biosimilar indicated for Crohn's disease, ulcerative colitis, plaque psoriasis and active psoriatic arthritis in adult patients."

Canada approval • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

PROPOSED USTEKINUMAB BIOSIMILAR FYB202: PHARMACOKINETIC EQUIVALENCE DEMONSTRATED IN A RANDOMISED, DOUBLE-BLIND, PARALLEL-GROUP, SINGLE-DOSE TRIAL IN HEALTHY SUBJECTS (RUSTIC) (UEGW 2024) - "The RUSTIC trial demonstrated bioequivalent PK characteristics between FYB202 and both EU-approved and US-licensed ustekinumab and for the two reference drugs. No clinically meaningful differences with respect to the overall safety, immunogenicity and local tolerability were observed."

Clinical • PK/PD data • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL12A • IL23A

Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi (ustekinumab) for the treatment of serious inflammatory diseases (Formycon Press Release) - "Formycon AG...and its commercialization partner Fresenius Kabi jointly announce that the European Commission (EC) has issued a marketing authorization for FYB202/Otulfi, a biosimilar to Stelara. The centralized marketing authorization is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway."

EMA approval • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

A randomised, double-blind trial to compare the efficacy, safety, and immunogenicity of the proposed biosimilar ustekinumab (FYB202) with reference ustekinumab in patients with moderate-to-severe plaque psoriasis (EADV 2024) - "Proposed biosimilar ustekinumab (FYB202) demonstrated therapeutic equivalence to reference ustekinumab in patients with moderate-to-severe plaque psoriasis, with comparable safety and immunogenicity profiles."

Clinical • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL23A

Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar Otulfi (ustekinumab-aauz) (Businesswire) - "Fresenius Kabi...and Formycon AG...announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Otulfi (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara (ustekinumab). Otulfi is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis....The FDA approval of Otulfi (ustekinumab-aauz) is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data....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."

FDA approval • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

New Ustekinumab Biosimilar Candidate FYB202: Pharmacokinetic Equivalence Demonstrated in a Randomized, Double-Blind, Parallel-Group, Single-Dose Trial in Healthy Subjects. (PubMed, Clin Pharmacol Drug Dev) - "In conclusion, the RUSTIC trial demonstrated equivalent PK characteristics for FYB202 when compared to both EU-Ref and US-Ref ustekinumab and between both reference drugs. It provides the basis for the marketing authorization of FYB202, together with an extensive analytical characterization and the results of a confirmatory efficacy and safety trial in patients with moderate to severe plaque psoriasis."

Clinical • Journal • PK/PD data • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis

Fresenius Kabi and Formycon Announce FDA Submission Acceptance for Review for Ustekinumab Biosimilar Candidate (Fresenius Kabi Press Release) - "Fresenius Kabi and its license partner Formycon announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for FYB202, a Ustekinumab biosimilar candidate. FYB202 references Johnson & Johnson’s Stelara^®, a human monoclonal antibody for the treatment of immune-mediated disorders."

BLA • Immunology

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

Formycon and Fresenius Kabi announce European Medicines Agency Submission Acceptance of the Marketing Authorization Application for FYB202, an Ustekinumab Biosimilar Candidate (PharmiWeb) - "Formycon AG...and its commercialization partner Fresenius Kabi today announced that the European Medicines Agency ('EMA') has accepted the Marketing Authorization Application ('MAA') for FYB202, a proposed biosimilar candidate to Stelara®."

European regulatory • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Formycon and Fresenius Kabi secure U.S. License Date for proposed Ustekinumab Biosimilar (PharmiWeb) - "Formycon AG...and Fresenius Kabi today announced that they have reached a settlement with Johnson & Johnson for the U.S., concerning FYB202, a proposed ustekinumab biosimilar to Stelara. The settlement allows Fresenius Kabi and Formycon to launch their product, once approved by the FDA, in the US no later than April 15, 2025."

Corporate lawsuit • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Formycon announces successful results of Phase I clinical trial for ustekinumab biosimilar candidate FYB202 and concludes clinical development (PipelineReview) - P1 | N=NA | "Formycon AG...today announced the successful conclusion of the extended Phase I clinical study comparing the pharmacokinetics of FYB202 and the reference drug Stelara....The positive results of the Phase I pharmacokinetics study successfully conclude the clinical development program. FYB202 was bioequivalent to the reference drug Stelara® sourced in the EU as well as in the U.S. for all primary endpoint parameters. European and U.S. regulatory submissions are still planned for the third quarter of 2023. Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets."

BLA • European regulatory • P1 data • Immunology • Psoriasis

VESPUCCI: A Double-blind Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=392 | Completed | Sponsor: Bioeq GmbH | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Formycon AG announces global license agreement with Fresenius Kabi for FYB202, a biosimilar candidate to Stelara (ustekinumab) (Market Screener) - “Formycon AG...announced the conclusion of a global license agreement with Fresenius Kabi AG (‘Fresenius Kabi’). Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets. Upon conclusion of the agreement Formycon receives an upfront payment as well as milestone payments contingent on the successful achievement of certain regulatory events which are expected to total in the mid double digit million Euro range….In the extended phase I pharmacokinetics study, the recruitment of study subjects was successfully completed in October 2022. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023.”

BLA • European regulatory • Licensing / partnership • Trial status • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

FORMYCON PUBLISHES PRELIMINARY FIGURES FOR THE FIRST HALF OF 2022 (Formycon Press Release) - "Preliminary operating result (EBIT) of Euro -8.5 million reflects planned investments in fully-owned projects FYB202, FYB206 and FYB207 as well as pipeline expansion with biosimilar projects FYB208 and FYB209...The preliminary figures do not yet include purchase price allocation effects from the ATHOS transaction closed in May where Formycon AG acquired 100% of the rights to FYB202, a biosimilar candidate for Stelara..."

Commercial • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

FORMYCON'S BIOSIMILAR USTEKINUMAB CANDIDATE FYB202 SHOWS COMPARABLE EFFICACY TO REFERENCE PRODUCT STELARA IN PHASE III STUDY (Formycon Press Release) - P3 | N=392 | NCT04595409 | Sponsor: Bioeq GmbH | "Formycon AG...today reported positive preliminary efficacy and safety data from VESPUCCI Phase III clinical trial for FYB202, its proposed biosimilar version of Stelara®(Ustekinumab)....The primary endpoint of the comparative global Phase III study measures the percent improvement of the Psoriasis Area and Severity Index (PASI) at 12 weeks from baseline. The values obtained for FYB202 and reference product are within the relevant equivalence limits. In addition, to date, no clinically meaningful differences in safety and immunogenicity have been observed....The extended Phase I pharmacokinetics study has commenced. Recruitment is evolving according to plan and a substantial number of subjects has already been enrolled in the study."

P3 data • Trial status • Immunology • Psoriasis

Formycon Q1 2022 Financial Results and Announcement of Two New Biosimilar Products (Big Molecule Watch) - "Formycon recently announced its sales and earnings figures for the first quarter of 2022. Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -4.0 million (Q1/previous year: EUR -1.7 million), which was in line with expectations...the reported revenues were mainly a result of development activities for late-stage biosimilar projects FYB201 (biosimilar candidate for LUCENTIS®), FYB202 (biosimilar candidate for STELARA®), and FYB203 (biosimilar candidate for EYLEA®)."

Financing • Age-related Macular Degeneration • Immunology • Inflammatory Bowel Disease

Formycon publishes Update on Development Projects (PharmiWeb) - "FYB202: Treatment of all patients in phase III clinical trial completed (last-patient-out) - primary efficacy endpoint data expected by end of July 2022...European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023 following the availability of these additional pharmacokinetic data."

BLA • European regulatory • P3 data • Trial status • Immunology • Psoriasis