Formycon's Biosimilar Ustekinumab Candidate FYB202 Shows Comparable Efficacy to Reference Product Stelara®* in Phase III Study

  • VESPUCCI study demonstrates the comparable efficacy of FYB202 to the reference product Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis)
  • Primary Efficacy Endpoint of the Global Phase III Study met
  • Comparative Phase I Pharmacokinetics Study in recruitment

MUNICH, Germany I August 16, 2022 I Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today reported positive preliminary efficacy and safety data from VESPUCCI Phase III clinical trial for FYB202, its proposed biosimilar version of Stelara®(Ustekinumab).

The multi-center, randomized, double-blinded, comparative clinical study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB202 and the reference medicine Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). This is the most common form of psoriasis, accounting for 80 to 90 percent of all cases.

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.

The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, Stelara® has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis as well as psoriatic arthritis. Its approved indications were expanded to chronic inflammatory bowel diseases like treatment of Crohn’s disease (2016) and ulcerative colitis (2019). Stelara® achieved a global sales volume of over USD 9 billion in 2021.

As a result of the transaction with ATHOS KG, which was successfully concluded in the first half of 2022, the global commercialization rights to FYB202 are held in full by Formycon AG (prior to the transaction 24.9% co-ownership share).

Formycon’s CEO Dr. Stefan Glombitza is pleased with the results: “With FYB202 we have a promising biosimilar candidate and are addressing an important and growing market in the inflammatory diseases segment. The positive interim phase III study results mark an important milestone and underline our expertise in the development of high-quality biosimilars.”

* Stelara® is a registered trademark of Johnson & Johnson

About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has six biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.

SOURCE: Formycon

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