Polpharma Biologics secures distribution of upcoming biosimilars
Polpharma Biologics SA and MS Pharma SA have signed licensing agreements for Polpharma's vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) biosimilars in the Middle East and North Africa (MENA) region.
Under the agreement, MS Pharma will be responsible for the registration, marketing, and distribution of Polpharma biologics‘ vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) biosimilars across MENA, while Polpharma Biologics will maintain responsibility for development, manufacturing, and supply. Furthermore, both parties have agreed to transfer fill and finish activities to the MENA region. These operations will be carried out at MS Pharma’s first of its kind biologics manufacturing facility in Saudi Arabia.
While there are no competitors for vedolizumab and guselkumab biosimilars, particularly in the MENA region, other ocrelizumab biosimilars are in Phase III tests at Celltrion (CT‑P53) and Amgen (ABP692). PB016 will be marketed ex-MENA by Fresenius Kabi.
Roche’s Ocrevus generated US$ 7.6bn in global sales in 2024, while sales of vedolizumab hit the US$ 6bn mark according to Entyvio. Johnson & Johnson reported that guselkumab achieved sales of around US$3.67bn in 2024—a growth of approximately 16.6% year-on-year.
Vedolizumab is a monoclonal antibody targeting α4β7 integrin (a molecule involved in the movement of immune cells to the gut), indicated for ulcerative colitis and Crohn’s disease. Ocrelizumab targets CD20-positive B cells, and by depleting them, helps reduce inflammation and slow the progression of disability in people with multiple sclerosis. Guselkumab is a monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23), a key cytokine involved in inflammatory and immune responses. It is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.
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