ROTKREUZ, Switzerland, July 31, 2026
Polpharma Biologics International AG announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA) for PB016, the company’s proposed vedolizumab biosimilar referencing Takeda’s Entyvio® (vedolizumab) intravenous formulation. The regulatory submissions mark a major milestone in the company’s biosimilar development program and reinforce its commitment to delivering high-quality, affordable biologic medicines for patients with moderately to severely active ulcerative colitis and Crohn’s disease. Developed and manufactured by Polpharma Biologics, PB016 will be commercialized globally by Fresenius Kabi, excluding the Middle East and North Africa, pending regulatory approvals.
Comprehensive Development Program Supports Regulatory Review
PB016 is a proposed biosimilar monoclonal antibody that selectively targets the α4β7 integrin, reducing gastrointestinal inflammation by preventing inflammatory lymphocytes from migrating into intestinal tissue. The regulatory applications are supported by an extensive analytical, non-clinical, and clinical development program designed to demonstrate high similarity to the reference product in accordance with global biosimilar approval requirements. Clinical evaluation included a Phase 1 trial in healthy volunteers and a Phase 3 clinical trial involving patients with ulcerative colitis (NCT05771155). According to the company, the acceptance of both applications validates its integrated capabilities spanning cell line development, manufacturing, regulatory strategy, and clinical development, representing a significant achievement in its expanding biosimilars portfolio.
PB016 Targets Growing Burden of Inflammatory Bowel Disease
Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease, affects approximately 2.4 million people in the United States and an estimated 2.5–3 million people across Europe, with global incidence continuing to increase. These chronic autoimmune disorders require long-term management and often rely on biologic therapies to control inflammation, prevent disease progression, and improve quality of life. By developing PB016, Polpharma Biologics aims to increase patient access to cost-effective biologic treatment options while maintaining the rigorous quality, efficacy, and safety standards required for biosimilar approval. The company believes broader availability of biosimilars can play an important role in improving healthcare access for patients with chronic inflammatory diseases worldwide.
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Strategic Partnership Supports Global Commercialization
Polpharma Biologics continues to strengthen its position in the global biosimilars market through strategic collaborations and integrated development expertise. Under its agreement with Fresenius Kabi, the partner will hold exclusive commercialization rights for PB016 worldwide, except in the Middle East and North Africa, once regulatory approvals are obtained. The collaboration combines Polpharma Biologics’ expertise in biosimilar research, development, manufacturing, and regulatory execution with Fresenius Kabi’s extensive global commercial infrastructure. Positive regulatory decisions from the FDA and EMA could expand treatment options for patients living with inflammatory bowel disease while supporting broader adoption of affordable biologic therapies across international healthcare markets.
Source: Polpharma Biologics, press release
