Polpharma Biologics and MS Pharma Sign Licensing Agreements for Proposed Vedolizumab (PB016), Ocrelizumab (PB018) and Guselkumab (PB019) Biosimilars

Polpharma Biologics S.A. (“Polpharma Biologics”), specialized in the development and manufacturing of biosimilars, today announced that it has signed licensing agreements with MS Pharma, a leading biosimilar production and distribution company in the Middle East and North Africa (MENA) region, for the commercialization of its biosimilar candidates vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) in the MENA region.

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.

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 - 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.

Kalle Känd, CEO of MS Pharma:

"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."

Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics Group:

"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."

About MS Pharma

MS Pharma is a leading regional pharmaceutical company in the MENA region, specializing in the development, production, and distribution of a broad portfolio of generic and biologic therapies. Positioned for rapid growth, the company operates five manufacturing facilities across Jordan, Algeria, and Saudi Arabia — home to a newly launched biologics plant, all serving the broader MENA market. Headquartered in Amman, Jordan, with management offices in Zug, Switzerland, MS Pharma employs over 2,000 people across 12 countries.

For more information, please visit http://www.mspharma.com

About Polpharma Biologics

Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas.

Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production preparing drugs for future commercial partnerships with global pharmaceutical organizations. The expertise of Polpharma Biologics lies in the development and manufacture of medicines based on microbial and mammalian expression systems. With its cell line development center in the Netherlands and two centers of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists.

Learn more at www.polpharmabiologics.com

Important Note

This press release is for informational purposes only and does not constitute promotional material for PB016, PB018 and PB019 in Poland or any other jurisdiction. The commercialization of proposed vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) biosimilars is solely the responsibility of MS Pharma, the marketing authorization holder, in accordance with all applicable laws and regulations.

Disclaimer

This press release is issued from Polpharma Biologics Group and is intended to provide worldwide information to healthcare professionals, media and (potential) investors about our global business in relation to drug development and manufacturing expertise. Although Polpharma Biologics Group is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). These statements involve inherent risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the approval and commercialization of the medicinal product, market reception, competition, changes in economic conditions and applicable laws, global regulatory developments, contractual risks and dependencies from third parties. Polpharma Biologics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. Moreover, Polpharma Biologics wishes to emphasize that this press release is for informational purposes only and shall not be construed as making any representation, warranties, or guarantees, either express or implied, regarding the potential approval, market reception, commercialization, or success of the medicinal product or any other product or therapy.

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