Ustekinumab biosimilar candidate

Our candidate biosimilar to Stelara®* (active ingredient: ustekinumab) is targeted at several different therapeutic indications involving serious inflammatory diseases.






Aristo Pharma GmbH

Current development status

Preclinical phase
Clinical phase I
Clinical phase III

Scope of therapeutic indication

Ustekinumab, a human monoclonal antibody which targets the cytokines interleukin-12 and interleukin-23, is used for the treatment of several different serious inflammatory diseases, such as moderate to severe psoriasis. Its therapeutic indications were extended to also include the treatment of Crohn’s disease and ulcerative colitis, both chronic inflammatory bowel diseases. In addition, the drug is also indicated for the treatment of psoriatic arthritis.

Our development work

By applying dozens of analytical methodologies, we have been able to demonstrate its analytical comparability to the reference product. An efficient manufacturing process for our biosimilar candidate has been developed and is now in place. We are currently in a phase III clinical trial, comparing the efficacy, safety, and immunogenicity of FYB202 and the reference product Stelara®. Bioeq GmbH is the sponsor of the clinical study and responsible for the design and operative execution. We have, in addition, filed our own patent applications, such as in the area of drug formulation.

At the end of 2017, we transferred the FYB202 project to a joint venture entity called “FYB 202 GmbH & Co. KG”, in which Formycon holds a 24.9 percent interest. The remaining 75.1 percent is owned by Berlin-based Aristo Pharma GmbH, which is part of Strüngmann Group. Under the terms of the deal, all development costs incurred subsequent to the pilot phase, as well as all prior project investments, will be allocated in proportion to the respective ownership shares. Likewise, both of the joint venture partners will share any future income from out-licensing or product sales in proportion to their ownership shares

The market

Stelara® is an expensive medication, with its price ranging from roughly EUR 4,500 for one low-dose application in the European Union to roughly USD 19,000 for a higher-dosed application in the United States.

Global sales of this relatively new drug were around USD 7.7 billion in 2020, with growth continuing at a rapid rate. The potential use of ustekinumab for additional therapeutic indications offers additional revenue potential.

Next milestones

The development project FYB202 has been in phase III clinical trial since November 2020. The objective of the joint venture is to drive forward with the development of FYB202 all the way through to regulatory approval. As with FYB201 and FYB203, Formycon will act as a service provider in carrying out portions of the remaining development work. Should the project proceed as planned, market launch would take place in the United States and in the European Union after expiration of the reference product’s patent protection.

* Stelara is a registered trademark of Johnson & Johnson