MS Pharma and Polpharma Biologics Partner to Expand Biosimilar Access in MENA

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MS Pharma, an Amman, Jordan-headquartered biosimilar production and distribution company in the Middle East and North Africa (MENA) region, announced on Sept. 2, 2025 that it has signed licensing agreements with Polpharma Biologics, a The Netherlands-based developer and manufacturer of biosimilars, to bring three proposed biosimilars—vedolizumab (PB016), ocrelizumab (PB018), and guselkumab (PB019)—to markets across MENA (1).

The deal underscores the growing role of regional partnerships in advancing biosimilar development, localizing biologics manufacturing, and expanding patient access to therapies for complex diseases. Under the agreement, Polpharma Biologics will remain responsible for development, manufacturing, and supply of the three biosimilar products. MS Pharma will oversee registration, marketing, and distribution throughout the region, with commercialization activities anchored at its biologics manufacturing facility in Saudi Arabia. The partners also plan to transfer fill/finish operations to the Saudi Arabia facility, which would make that facility the first of its kind in that region (1).

What three key therapeutic areas do these biosimilars target?

The three proposed biosimilar products target three high-need therapeutic areas: gastroenterology, neurology, and dermatology. Access to biologic treatments in these therapeutic areas has historically been limited due to cost and availability.

Kalle Känd, CEO of MS Pharma, described the collaboration as a key step in strengthening the company’s therapeutic portfolio. “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,” Känd said in a company press release (1).

Vedolizumab is a monoclonal antibody directed against α4β7 integrin, a molecule that regulates immune cell trafficking to the gut. It is indicated for ulcerative colitis and Crohn’s disease, two chronic inflammatory bowel diseases that often require long-term biologic treatment.

Ocrelizumab works by depleting CD20-positive B cells, a mechanism that reduces inflammation and slows disability progression in people with multiple sclerosis. Its role in neurology makes it an important therapeutic option where disease-modifying treatments are in high demand.

Guselkumab selectively binds to the p19 subunit of interleukin-23, a cytokine central to inflammatory and immune responses. Approved for moderate to severe plaque psoriasis and active psoriatic arthritis, guselkumab has reshaped treatment strategies in dermatology by providing a targeted, long-term approach to disease management (2,3).

Together, these biosimilars have the potential to significantly broaden access to high-quality biologic therapies for patients across MENA.

What industry trends does this collaboration highlight?

“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,” said Konstantin Matentzoglu, supervisory board member of Polpharma Biologics Group, in the release.

With this agreement several key industry trends are highlighted, including the globalization of biosimilar development, the increasing push to localize biologics manufacturing, and the critical role of partnerships in accelerating access to therapies. By situating fill/finish operations in Saudi Arabia, the collaboration not only expands regional capacity but also signals a shift toward building biologics infrastructure closer to patient populations.

As biologics continue to dominate therapeutic innovation, agreements such as this highlight the importance of advancing biosimilar pipelines in parallel. The move also reinforces the growing recognition that sustainable healthcare systems depend on making these therapies more affordable and accessible—a goal that resonates across drug manufacturing and development communities worldwide (4).

References

1. Polpharma Biologics. Polpharma Biologics and MS Pharma Sign Licensing Agreements for Proposed Vedolizumab (PB016), Ocrelizumab (PB018) and Guselkumab (PB019) Biosimilars. Press Release. Sept. 2, 2025.
2. Puig, L.; Costanzo, A.; de Jong, E. M. G. J.; et al. Guselkumab-Treated Patients with Plaque Psoriasis Who Achieved Complete Skin Clearance for ≥ 156 Consecutive Weeks: A Post-Hoc Analysis From the VOYAGE 1 Clinical Trial. Am J Clin Dermatol. 2024, 25 (2), 315–325. DOI: 10.1007/s40257-023-00816-1
3. Ritchlin, C. T.; Mease, P. J.; Boehncke, W. H.; et al. Durable Control of Psoriatic Arthritis with Guselkumab Across Domains and Patient Characteristics: Post Hoc Analysis of a Phase 3 Study. Clin. Rheumatol. 2024, 43 (8), 2551–2563. DOI: 10.1007/s10067-024-06991-8
4. Ntais, C.; Kontodimopoulos, N.; Fanourgiakis, J.; Talias, M. A. Fostering Healthcare System Sustainability Through Efficient Practices: Can Adopting Biosimilars Ease the Financial Burden of Rheumatoid Arthritis? F1000Res. 2025, 13, 1128. DOI: 10.12688/f1000research.156983.2