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Polpharma Biologics Inks Exclusive Licensing Deal with Tuteur for Autoimmune Disease Biosimilar in LATAM

May 22, 2026

On 22 May 2026, Polpharma Biologics and Tuteur announced that they have entered into an exclusive licensing agreement for the commercialisation of an unnamed biosimilar for the treatment of an autoimmune disease in Latin America, excluding Brazil.

Under the agreement, Swiss-based Polpharma Biologics will be responsible for the development, manufacture and supply of the product, while Argentina-based Tuteur will be responsible for the commercialisation, marketing and distribution across Latin America, excluding Brazil.

The unnamed biosimilar is currently in development, with the companies anticipating a regulatory submission to be filed within the next three years.

In December 2025, Polpharma Biologics entered into an exclusive licensing agreement with Libbs Farmacêutica, for the commercialisation of an unnamed biosimilar for autoimmune diseases in Brazil.  This deal followed a licensing agreement between Polpharma and MS Pharma in September 2025 for the commercialisation in the MENA region of biosimilars to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®).  In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).