Commercialization Agreement for Bio-Thera’s Investigational Ustekinumab Biosimilar

Bio-Thera Solutions has partnered with London-based Hikma Pharmaceuticals on its proposed ustekinumab biosimilar BAT2206. The agreement will give exclusive rights to commercialize BAT2206 in the US after FDA approval, with the potential for marketing rights in Europe as well.

Although the Hikma Pharmaceuticals USA name is not well known in the US, it does have a base of operations in Ohio, resulting from its 2015 acquisition of Roxane Laboratories. Hikma is also partnered with Civica Rx to supply eight essential injectable medications. Roxane, a significant manufacturer of generic agents, is active internationally.

The principal patents for this interleukin 12/23 inhibitor (reference product, Stelara®) expire in late 2023. Annual US sales of Stelara are well above the $4 billion mark. The near-term patent expiration and blockbuster revenues have sparked plenty of interest in ustekinumab biosimilars. At least six biopharmaceutical companies, including Bio-Thera Solutions, have publicly announced development programs for ustekinumab biosimilars.

Bio-Thera’s phase 1 study of BAT2206 in healthy volunteers is due to be completed this month. According to, a phase 3 study in 406 patients with moderate-to-severe plaque psoriasis was to start in February and be completed in May 2023.

In other biosimilar news…The Biden Administration supports several initiatives for reducing drug costs, including allowing Medicare to negotiate directly for Part B and Part D drugs, in addition to increased incentives for doctors and hospitals to administer biosimilars. However, it will be up to a divided Congress to enact these initiatives.

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