Ustekinumab (Stelara) Biosimilars Pipeline Review

Reference Product: Stelara

Target: Interleukin-12 and interleukin-23 p40 subunit (IL-12/IL-23 p40)

Product Categories: Antibodies

This product provides basic information on approved drugs and drug candidates in research and development as biosimilar antibodies of Stelara (ustekinumab).

This product consists of:

• Competitors described in a tabular format covering drug code/INN, target(s)/MoA, class of compound, territory of main competitor, indication(s) & R&D stage.
• Project History with link to source of information (press release, homepage, abstracts, presentations, annual reports etc).
• One-month online access to La Merie Publishing’s database for ustekinumab (Stelara) biosimilars (prerequisite: access to internet).

This product is delivered on the very same day by e-mail containing competitor and project history reports in pdf format and database credentials. Reports are prepared on the same day.

Developed by Janssen Biotech, the blockbuster therapeutic antibody STELARA (INN: ustekinumab) is an approved human interleukin-12 and interleukin-23 antagonist indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients (6 years or older) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis in adults, as well as for adult patients with moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis. Stelara was approved in the US and EU in 2009. The Stelara patent expires September 2023 in the United States.

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.