MedPath

Formycon's Ustekinumab Biosimilar FYB202 Shows Comparable Efficacy to Stelara® in Clinical Studies

• Formycon's FYB202 demonstrated analytical and functional comparability to reference ustekinumab (Stelara®) through comprehensive laboratory testing and clinical studies.

• Phase III efficacy study involving 392 psoriasis patients and Phase I pharmacokinetics study with 491 healthy volunteers confirmed therapeutic equivalence of FYB202.

• The biosimilar received regulatory approvals from FDA, EMA, Health Canada, and UK's MHRA between September 2024 and January 2025, expanding treatment access.

Formycon AG has unveiled comprehensive clinical data supporting the comparability of its ustekinumab biosimilar FYB202 to the reference product Stelara® at the European Crohn's and Colitis Organisation (ECCO) Congress in Berlin. The presentation highlights successful outcomes from both phase I and phase III clinical studies, supported by detailed analytical comparability data.

Analytical and Functional Comparability

Advanced laboratory analysis confirmed FYB202's structural and functional similarity to the reference product. The biosimilar demonstrated comparable physicochemical and biological properties, including critical quality attributes such as structure, function, purity, and potency. Functional comparability was specifically verified through IL-12 and IL-23 binding tests and bioassays, addressing the primary mechanism of action.

Clinical Trial Results

The therapeutic equivalence of FYB202 was established through two key clinical studies:
  • A Phase I pharmacokinetics study involving 491 healthy volunteers
  • A Phase III efficacy study including 392 patients with moderate to severe plaque psoriasis
These comprehensive results support the extrapolation of FYB202's efficacy to all approved indications of the reference drug, confirming its potential as a safe and effective alternative for patients requiring ustekinumab treatment.

Regulatory Status and Treatment Applications

FYB202, an interleukin inhibitor, received marketing authorization from multiple regulatory bodies:
  • European Medicines Agency (EMA) and FDA approval in September 2024
  • Health Canada and UK's MHRA approval in January 2025
The biosimilar is indicated for use in both dermatological conditions, specifically psoriasis, and gastroenterological applications for chronic inflammatory bowel disease management.

Market Impact and Healthcare Access

The development of FYB202 represents a significant advancement in expanding patient access to critical biological therapies. As part of Formycon's growing biosimilar portfolio, which includes approved products like FYB201 (ranibizumab) and FYB203 (aflibercept), FYB202 contributes to the company's mission of providing cost-effective alternatives to established biologic treatments.
The data presentation at ECCO 2025 (Poster ID: P0879) will take place during the guided poster session on February 21, 2025, offering healthcare professionals detailed insights into the biosimilar's development and clinical performance.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Formycon Halts Phase III Trial of FYB206 Following FDA Feedback, Faces Market Challenges for Biosimilars

Formycon terminates Phase III "Lotus" trial for FYB206 biosimilar after FDA confirms therapeutic comparability can be demonstrated through existing melanoma study data and analytical program.
Company anticipates significant valuation adjustments for FYB202 due to higher-than-expected price discounts in the U.S. biosimilar market, potentially requiring impairment in the high double-digit to low triple-digit million range.

Formycon's Aflibercept Biosimilar (FYB203) Gains EU Approval for Retinal Diseases

The European Commission has granted marketing authorization for Formycon's FYB203 (aflibercept) biosimilar, to be marketed as AHZANTIVE® and Baiama®.
FYB203 is approved for treating neovascular age-related macular degeneration (nAMD) and other retinal diseases like diabetic macular edema (DME).

Otulfi (Ustekinumab) Biosimilar Gains Regulatory Approvals in Canada and the UK for Inflammatory Diseases

Health Canada approved Otulfi, a ustekinumab biosimilar, for subcutaneous and intravenous use in treating Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis.
The UK's MHRA also approved Otulfi for the same indications, following approvals in the US and Europe, expanding treatment options for inflammatory diseases.

Formycon Partners with MS Pharma to Commercialize Ustekinumab Biosimilar in MENA Region

Formycon AG and MS Pharma have entered into a licensing and supply agreement for the commercialization of FYB202, a biosimilar to Stelara® (ustekinumab), in the Middle East and North Africa (MENA) region.
MS Pharma will have the rights to license, commercialize, and produce FYB202 locally in Saudi Arabia for GCC countries and other MENA countries, enhancing patient access to vital treatments.

Formycon's Aflibercept Biosimilar (FYB203) Receives Positive CHMP Opinion for EU Approval

Formycon's FYB203, a biosimilar to aflibercept (Eylea®), has received a positive opinion from the CHMP for marketing authorization in the EU.
The CHMP recommends FYB203, to be marketed as AHZANTIVE® and Baiama®, for treating nAMD, DME, CNV, and macular edema following RVO.

CHMP Issues Positive Opinion for Formycon's Aflibercept Biosimilar FYB203

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Formycon's FYB203, an aflibercept biosimilar, marking a significant step toward EU market entry.
FYB203 demonstrated equivalent quality, efficacy, and safety to the reference product, Eylea, in comprehensive analytical, pre-clinical, and clinical assessments.

FDA Approves Otulfi, a Stelara Biosimilar, for Inflammatory Conditions

The FDA has approved Otulfi (ustekinumab-aauz) as a biosimilar to Stelara, offering a new treatment option for Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Otulfi, developed by Formycon and Fresenius Kabi, demonstrated comparable efficacy, safety, and immunogenicity to Stelara in clinical trials.

Celltrion's Ustekinumab Biosimilar SteQeyma Approved in Europe; Zymfentra Access Expands

The European Commission approved Celltrion's SteQeyma, an ustekinumab biosimilar referencing Stelara, for treating chronic inflammatory diseases across gastroenterology, dermatology, and rheumatology.
Celltrion USA partnered with Cigna Healthcare and Express Scripts to broaden patient access to Zymfentra (infliximab-dyyb) for ulcerative colitis and Crohn's disease.

Fresenius Kabi and Formycon Announce FDA Submission for FYB202, a Ustekinumab Biosimilar Candidate

Fresenius Kabi and Formycon have announced the FDA's acceptance for review of the Biologics License Application for FYB202, a biosimilar candidate to Johnson & Johnson’s Stelara®, aimed at treating immune-mediated disorders.

Celltrion Pursues Adalimumab Interchangeability as Formycon Reports Positive Ustekinumab Biosimilar Data

Celltrion Healthcare has filed an investigational new drug application with the FDA for a Phase 3 clinical trial to establish interchangeability of its adalimumab biosimilar, Yuflyma, with Humira.
The Phase 3 trial will involve switching patients between Humira and Yuflyma to verify pharmacokinetics, efficacy, and safety in 366 patients with plaque psoriasis.

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy