Polpharma Biologics, specialised in the development and manufacturing of biosimilars, has announced that it has signed licensing agreements with MS Pharma, a biosimilar production and distribution company in the Middle East and North Africa (MENA) region, for the commercialisation of its biosimilar candidates vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) in the MENA region.
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Under the agreements, MS Pharma will be responsible for the registration, marketing, and distribution of these three 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.
Kalle Känd, CEO of MS Pharma, said: "Expanding our biosimilar portfolio in high-need therapeutic areas such as gastroenterology, neurology, and dermatology is a strategic priority. These three products will significantly strengthen our offering and reinforce our leadership in the MENA region. Partnering once again with Polpharma Biologics underscores our commitment to delivering high-quality, accessible biologic medicines to patients across the region, through localizing advanced biologics production."
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.
Together, these biosimilars represent significant potential to expand access to high-quality, affordable biologic therapies for patients in the region.
Konstantin Matentzoglu, supervisory board member of Polpharma Biologics Group, said: "We are proud to extend our collaboration with MS Pharma. Their deep regional expertise and strong commercial network make them an ideal partner to bring our biosimilar medicines to more patients in MENA, helping improve treatment accessibility and sustainability of healthcare systems."