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

LOW ADA AND NAB INCIDENCE WITH FYB202, A BIOSIMILAR TO USTEKINUMAB, IN HEALTHY VOLUNTEERS AND PATIENTS WITH PLAQUE PSORIASIS (UEGW 2025) - "FYB202 demonstrated biosimilarity to the reference ustekinumab. The consistently lower ADA incidence after treatment with FYB202 compared to the reference may reflect differences in the expression system, with FYB202 produced using state of the art technologies in Chinese hamster ovary cells (CHO) versus murine myeloma cells (SP2/0) for the reference, which could leading to slightly different glycosylation profiles2. These findings support FYB202 as a safe and effective treatment option for plaque psoriasis."

Clinical • Dermatology • Hematological Malignancies • Immunology • Inflammation • Multiple Myeloma • Psoriasis • IL23A

Safe Switching from Originator Ustekinumab to FYB202 Ustekinumab Biosimilar in subjects with Moderate-to-severe Plaque Psoriasis: Efficacy, Safety and Immunogenicity data following Treatment Transition in a Pivotal, Randomized, Double-blind, Phase III Study (EADV 2025) - "Patients who transitioned from reference ustekinumab to FYB202 at W28 demonstrated similar efficacy, safety, and immunogenicity up to W52 compared to patients who continued with reference ustekinumab."

Clinical • P3 data • Crohn's disease • Dermatology • Diabetes • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Novel Coronavirus Disease • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL23A

Safe Switching from Originator Ustekinumab to FYB202 Ustekinumab Biosimilar in subjects with Moderate-to-severe Plaque Psoriasis: Efficacy, Safety and Immunogenicity data following Treatment Transition in a Pivotal, Randomized, Double-blind, Phase III Study (EADV 2025) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Psoriasis

Totality of Evidence Supporting the Development of an Ustekinumab Biosimilar in Moderate to Severe Plaque Psoriasis: Analytical, Pharmacokinetic, and Clinical Outcomes Including Quality of Life Impact (EADV 2025) - "We present the totality of evidence supporting FYB202, a EU-approved and US-licenced ustekinumab biosimilar, with emphasis on early clinical response, symptom relief and quality of life improvement through Week 28... The ustekinumab biosimilar demonstrated comprehensive similarity to the reference product across all analytical, pharmacokinetic, and clinical measures. Improvements in disease severity, quality of life, and itch burden were comparable through Week 28, supporting the ustekinumab biosimilar as an effective and accessible treatment option for moderate to severe plaque psoriasis."

Clinical • Clinical data • HEOR • PK/PD data • Dermatology • Immunology • Pruritus • Psoriasis

Low ADA and NAb Incidence with FYB202, a Biosimilar to Ustekinumab, in Healthy Volunteers and Patients with Plaque Psoriasis (EADV 2025) - "FYB202 demonstrated biosimilarity to the reference ustekinumab. The consistently lower ADA incidence after treatment with FYB202 compared to the reference may reflect differences in the expression system, with FYB202 produced in Chinese hamster ovary cells (CHO) versus murine myeloma cells (SP2/0) for the reference, leading to slightly different glycosylation profiles2. These findings support FYB202 as a safe and effective treatment option for plaque psoriasis."

Clinical • Dermatology • Hematological Malignancies • Immunology • Inflammation • Multiple Myeloma • Psoriasis • IL23A

Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study. (PubMed, BioDrugs) - "The comparative clinical efficacy studies revealed no additional information. This finding adds on to the evidence that clinical PK and the comparative analytical assessment, specifically the comparison of quality attributes with potential immunogenic relevance, suffice for the evaluation of immunogenicity of biosimilars in general."

Journal • Review

Biosimilar FYB202 Shows Therapeutic Equivalence to Ustekinumab for Plaque Psoriasis (Center for Biosimilars) - P3 | N=392 | VESPUCCI (NCT04595409) | Sponsor: Bioeq GmbH | "Researchers conducted a multicenter randomized, double blind, parallel group phase 3 study across 27 sites in Estonia, Georgia, Poland, and Ukraine. About 40% of the patient population was women with an average age of 42 years, with a 24.4 mean Psoriasis Area and Severity Index (PASI) score. Of the patients, 19.4% reported prior systemic biological treatment for psoriasis, and only 9.2% of these reported an inadequate response or intolerance....Both treatments patients tolerated well, and researchers found the safety profiles comparable between groups."

P3 data • Psoriasis

Fresenius Kabi to announce the commercial launch of Otulfi, an approved Ustekinumab Biosimilar in Canada (WVNews) - "Fresenius Kabi Canada announces that its ustekinumab biosimilar, developed by Formycon AG, is now commercially available in Canada. Otulfi is indicated for the treatment of several serious inflammatory diseases and benefiting more patients with autoimmune conditions. It is the third Fresenius Kabi immunology biosimilar approved in Canada for the treatment of Gastroenterology, Dermatology or Rheumatology conditions, providing treatment flexibility to manage patients at different stages of their autoimmune conditions....Otulfi is available for adult patients with moderate to severe active Crohn's disease, moderate to severe active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis indications, consistent with the adult indications of the originator biologic Stelara."

Launch Canada • Crohn's disease • Immunology • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

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

Crohn's disease • Psoriasis • Ulcerative Colitis

Ustekinumab in the Treatment of Crohn's Disease-A Narrative Review on Clinical Efficacy and Safety Profile. (PubMed, Pharmacy (Basel)) - "The review discusses the available data on the efficacy and safety of UST, as well as its comparison with other biologic therapies, such as infliximab and adalimumab...The therapeutic value of UST is also confirmed by biosimilars such as ABP 65 and FYB202, which show comparable efficacy and safety profile. The analysis of predictive biomarkers, such as serum drug levels and baseline eosinophil levels, could be an important element in the future personalization of CD treatment. The review's findings point to the importance of further research to improve the tailoring of therapies to individual patients and improve long-term treatment outcomes."

Journal • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • IL12A • IL23A

Mirikizumab (Omvoh) - an IL-23 antagonist for Crohn's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL23A

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

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