Tagged as: Stelara

Formycon Announces Comparable Efficacy of Ustekinumab Biosimilar to Reference Product STELARA in Phase III Study

This week Formycon AG (“Formycon”) announced positive preliminary efficacy and safety data from the VESPUCCI Phase III clinical trial for FYB202, Formycon’s biosimilar version of STELARA (ustekinumab). The Phase III study was a multi-center, randomized, double-blinded, comparative study of patients with moderate to severe psoriasis vulgaris (plaque psoriasis). The clinical…

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Formycon Q1 2022 Financial Results - Big Molecule Watch

First Quarter Earnings Graphic

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.  According to the press release, the reported revenues were mainly a result…

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Alvotech Announces Positive Top-Line Results from Clinical Trial for Ustekinumab Biosimilar

On May 24, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a confirmatory clinical trial for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab). STELARA® is prescribed to treat a variety of inflammatory conditions, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Alvotech notes that its trial…

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Alvotech Announces Positive Results from a Pharmacokinetic Similarity Study for Ustekinumab Biosimilar

On May 16, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab).  Alvotech notes that the study used “a single dose, 3-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose…

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Formycon AG Acquires Biosimilar Assets Ustekinumab and Ranibuzumab

On May 10, 2022, Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) announced that they have closed a transaction regarding the biosimilar assets FYB201 (ustekinumab) and FYB202 (ranibuzumab).  According to the press release, Formycon has acquired 100% of the rights in FYB202, a biosimilar candidate for STELARA®, and ATHOS’s 50% stake…

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FDA Approvals and Applications Update

On October 22, 2021, the FDA approved Genentech’s SUSVIMO (ranibizumab injection) for wet age-related macular degeneration (AMD) based on positive results from an open-label Phase III study. According to the Genentech press release, SUSVIMO, previously called Port Delivery System with ranibizumab, offers an alternative route of administration for anti-VEGF in…

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Bio-Thera Solutions and Hikma Pharmaceuticals Enters Into Ustekinumab Biosimilar Agreement

Last week, Bio-Thera Solutions and Hikma Pharmaceuticals announced they have entered into an exclusive commercialization and license agreement to commercialize the proposed ustekinumab biosimilar product, BAT2206. According to the press release, Bio-Thera will “maintain responsibility for development, manufacturing, and supply of BAT2206 [and] Hikma will have exclusive rights to commercialize…

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First Patient Dosed with Stelara® biosimilar in Bio-Thera Solutions’ Phase III Clinical Trial for Moderate to Severe Psoriasis

Last week, Bio-Thera Solutions announced that a first patient has been dosed in its Phase III clinical trial study for ustekinumab biosimilar BAT2206. Stelara® (ustekinumab) is marketed by Johnson & Johnson Corp. for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn’s disease…

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