Formycon Starts Phase 1 Trial for Proposed Ustekinumab Biosimilar

Drug maker Formycon announced today that it has begun a phase 1 clinical trial of its proposed ustekinumab biosimilar, FYB202, referencing Stelara. Ustekinumab is the first available therapy to target the interleukin-12 and -23 pathway.

The reference drug is FDA-approved to treat inflammatory conditions including Crohn disease, psoriatic arthritis, and plaque psoriasis. Stelara’s sponsor, Janssen, announced last week that the FDA has also approved the product for the treatment of ulcerative colitis.

Formycon’s phase 1 trial, which began dosing participants last week, is sponsored by Bioeq GmbH, which conducted the trial design and is handling clinical operation. Formycon is developing the biosimilar in partnership with Aristo Pharma GmbH.

If the phase 1 trial and a subsequent phase 3 confirmatory trial prove to be successful and lead to regulatory approval, Formycon indicated in a statement, the biosimilar could launch after Stelara’s patent exclusivity ends in September 2023 in the United States and in July 2024 in the European Union.

In addition to its proposed ustekinumab product, Formycon is also developing proposed biosimilars of ranibizumab, referencing Lucentis; aflibercept, referencing Eylea; and an undisclosed biologic product.

Formycon is the second biosimilar developer to announce a clinical trial of a ustekinumab biosimilar in recent weeks; earlier this month, NeuClone indicated that it has also begun dosing participants with its proposed ustekinumab biosimilar in a phase 1 trial. The single-dose, double-blind, randomized, 3-arm, multicenter study is being conducted in Australia in more than 200 healthy volunteers.

According to Formycon, sales of the brand-name Stelara totaled more than $5 billion in 2018 and continue to grow at a rapid rate. Expanding labels for the drug, it adds, offer additional revenue potential in the market.