Recent Ustekinumab and Denosumab Biosimilars Deals

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On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia.  According to the partnership agreement, Tabuk will hold the marketing authorization and be responsible to manufacture, register, import, and market BAT2206 in Saudi Arabia, leveraging its strong local presence and expertise.  Bio-Thera will handle the development and supply from China.  Bio-Thera has filed for regulatory approval of BAT2206 with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA).

Also on December 24, 2024, GlycoNex, Inc. announced a licensing agreement granting exclusive rights to develop, gain regulatory approval for, and commercialize GlycoNex’s SPD8, a proposed denosumab biosimilar to Amgen’s PROLIA and XGEVA.  GlyCoNex is a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies.  The licensee is not identified in GlycoNex’s press release.

Stay up to date on biosimilar news, applications and approvals in the Greater China by following our Big Molecule Watch China blog.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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