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Formycon to Present Clinical Data on FYB202 (Ustekinumab) Later This Month

Sep 17, 2024

Formycon has announced that it will present study data for Fymskina (FYB202), biosimilar to Janssen’s Stelara® (ustekinumab), at the 2024 European Academy of Dermatology and Venerology Congress (25 to 28 September in Amsterdam) and the 2024 United European Gastroenterology Week (12 to 15 October in Vienna).

The data which Formycon will present at the Congress arises out of the randomised, double-blind, multicentre VESPUCCI Phase III study which demonstrated that FYB202 has similar efficacy to the reference drug Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

The data which Formycon will present at the United European Gastroenterology Week will focus on Formycon’s Phase 1 pharmacokinetics study which showed that FYB202 is bioequivalent to the reference drug Stelara® for all primary endpoints.

The presentation of this data follows the European Medicines Agency’s Committee for Medicinal Products for Human Use’s (CHMP) positive recommendation for Formycon’s Fymskina (FYB202) at its July 2024 meeting.  The CHMP also adopted positive recommendations for two other biosimilars to Stelara® at its July meeting: Samsung Bioepis’ Eksunbi and Fresenius Kabi’s Otulfi (FYB202).  Fresenius Kabi is Formycon’s commercialisation partner for FYB202.

The CHMP positive opinions follow earlier EU approvals with Alvotech/Stada’s Uzpruvo® approved in January 2024, Samsung Bioepis’ Pyzchiva® in April 2024, and Amgen’s WezenlaTM in June 2024.  On 1 July 2024, CHMP also recommended marketing authorisation for Celltrion’s Steqeyma® (CT-P47, ustekinumab).  Bio-Thera is behind the race on this molecule, announcing on 24 July 2024 that its MAA for BAT2206 (ustekinumab) was EMA accepted.