Polpharma Biologics Advances PB016 as FDA and EMA Accept Biosimilar Applications for Review
Polpharma Biologics International AG has announced a significant regulatory milestone with the acceptance of both its Biologics License Application (BLA) by the U.S. Food and Drug Administration (FDA) and its Marketing Authorisation Application (MAA) by the European Medicines Agency (EMA) for PB016, the company’s proposed biosimilar to Takeda’s reference biologic Entyvio® (vedolizumab). The candidate is being developed as an intravenous (IV) lyophilized formulation for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease, two chronic forms of inflammatory bowel disease (IBD).
The simultaneous acceptance of regulatory submissions by two of the world’s leading health authorities marks an important advancement for Polpharma Biologics as it continues to expand its biosimilar portfolio. The milestone also reflects the company’s long-term strategy of delivering high-quality, affordable biologic medicines that can improve access for patients living with chronic immune-mediated diseases.
If approved, PB016 will provide physicians and patients with an additional treatment option that is designed to offer comparable safety, efficacy, and quality to the reference medicine while helping broaden access to advanced biologic therapies across global healthcare systems.
Regulatory Review Represents an Important Development Milestone
Acceptance of both the BLA and MAA means that the FDA and EMA have completed their initial assessments and determined that the submitted applications contain sufficient scientific and technical information to proceed with a full regulatory review.
These reviews will evaluate all aspects of the biosimilar application, including:
- Analytical similarity to the reference product
- Manufacturing quality and consistency
- Pharmacokinetic and pharmacodynamic data
- Clinical safety
- Clinical efficacy
- Immunogenicity
Successful acceptance for review represents a critical step before potential marketing authorization in the United States and the European Union.
For Polpharma Biologics, the milestone validates years of investment in biosimilar research, process development, manufacturing infrastructure, and global clinical development.
PB016 Developed as a Biosimilar to Vedolizumab
PB016 has been developed as a proposed biosimilar to vedolizumab, a monoclonal antibody marketed by Takeda under the brand name Entyvio®.
Vedolizumab belongs to a class of medicines known as integrin receptor antagonists. Unlike broader immunosuppressive therapies, vedolizumab selectively targets inflammatory processes within the gastrointestinal tract by blocking the interaction between α4β7 integrin and its receptor in the intestinal lining.
This targeted mechanism helps reduce inflammation while limiting immune activity primarily to the digestive system.
Vedolizumab is widely used for treating adults with:
- Moderately to severely active ulcerative colitis
- Moderately to severely active Crohn’s disease
These conditions are chronic inflammatory bowel diseases characterized by recurring inflammation of the gastrointestinal tract, causing symptoms such as abdominal pain, diarrhea, rectal bleeding, fatigue, weight loss, and reduced quality of life.
For many patients whose disease is not adequately controlled with conventional therapies, biologic medicines such as vedolizumab have become an important component of long-term disease management.
Comprehensive Development Program Supported the Applications
According to Polpharma Biologics, PB016 was developed through a comprehensive biosimilar development program designed to satisfy regulatory requirements established by global health authorities.
The program included extensive evaluations demonstrating high similarity between PB016 and the reference biologic across multiple areas.
These studies included:
- Detailed analytical characterization
- Structural and functional comparisons
- Non-clinical investigations
- Pharmacokinetic evaluations
- Clinical efficacy assessments
- Safety monitoring
- Immunogenicity analyses
The clinical development program featured:
Phase 1 Clinical Trial
An early-stage study involving healthy volunteers evaluated the pharmacokinetic profile, safety, and similarity of PB016 compared with the reference product.
Phase 3 Clinical Trial
The pivotal Phase 3 study enrolled patients with ulcerative colitis to evaluate the clinical performance of PB016 against the reference biologic.
The trial was designed to demonstrate equivalent efficacy, comparable safety, and similar immunogenicity, supporting biosimilar approval under regulatory standards.
Collectively, these studies formed the scientific foundation of the BLA and MAA submissions.
Integrated Development and Manufacturing Platform
Polpharma Biologics emphasized that PB016 reflects the capabilities of its fully integrated biosimilar development platform.
The company managed the entire development process internally, including:
- Cell line development
- Upstream process development
- Downstream purification
- Analytical testing
- Clinical manufacturing
- Commercial manufacturing preparation
This vertically integrated approach allows greater control over product quality, manufacturing consistency, and supply reliability throughout the development lifecycle.
The company also confirmed that PB016 will be manufactured within its own production facilities if regulatory approvals are obtained.
Partnership with Fresenius Kabi
Commercialization of PB016 will be supported through a strategic partnership with Fresenius Kabi, an operating company of Fresenius and a global provider of healthcare products and biologic medicines.
Under the collaboration agreement:
- Polpharma Biologics is responsible for developing and manufacturing PB016.
- Fresenius Kabi holds exclusive worldwide commercialization rights.
The commercialization agreement covers global markets except for the Middle East and North Africa (MENA) region.
Following regulatory approval, Fresenius Kabi will leverage its established international commercial infrastructure to make PB016 available across healthcare systems worldwide.
The partnership combines Polpharma Biologics’ expertise in biosimilar development and manufacturing with Fresenius Kabi’s global distribution network and commercial capabilities.
Leadership Highlights Regulatory Achievement
Anjan Selz, Chief Executive Officer of Polpharma Biologics International AG, described the FDA and EMA acceptances as major milestones for the company.
He noted that the regulatory progress validates the organization’s scientific expertise in biosimilar research, development, and manufacturing.
According to Selz, PB016 represents the culmination of years of rigorous scientific work spanning every stage of biosimilar development—from establishing the production cell line to completing comprehensive clinical studies required for regulatory submissions.
He also highlighted the strategic collaboration with Fresenius Kabi, emphasizing that the partnership will help ensure patients worldwide gain access to high-quality, affordable biologic treatment options for chronic inflammatory diseases if approvals are granted.
Growing Need for Additional Treatment Options
Inflammatory bowel disease continues to represent a major global healthcare challenge.
IBD primarily includes two chronic conditions:
- Ulcerative colitis
- Crohn’s disease
Together, these diseases affect approximately:
- 2.4 million people in the United States
- Between 2.5 and 3 million people across Europe
The global prevalence of IBD has continued to increase over recent decades, particularly in newly industrialized countries where incidence rates are rising steadily.
Although significant advances in treatment have improved disease management, neither ulcerative colitis nor Crohn’s disease currently has a definitive cure.
Patients often require lifelong therapy aimed at controlling inflammation, maintaining remission, preventing complications, and improving quality of life.
Without effective treatment, chronic inflammation may lead to:
- Hospitalization
- Intestinal strictures
- Fistula formation
- Surgery
- Long-term disability
Biologic therapies have transformed treatment outcomes for many patients by providing targeted immune modulation, particularly for individuals who do not respond adequately to conventional medications.
Biosimilars May Improve Patient Access
Despite their clinical benefits, biologic therapies remain among the most expensive medicines used in gastroenterology.
High treatment costs can create barriers to patient access in many healthcare systems around the world.
Biosimilars are developed to provide highly similar alternatives to approved biologic medicines while maintaining comparable:
- Safety
- Effectiveness
- Quality
- Clinical performance
By increasing market competition, biosimilars have the potential to reduce healthcare costs and improve patient access to advanced therapies.
Greater availability of biosimilars may also enable physicians to initiate biologic treatment earlier in the disease course, potentially improving long-term clinical outcomes for patients living with chronic inflammatory bowel disease.
Strengthening Polpharma Biologics’ Biosimilar Portfolio
The acceptance of the FDA and EMA applications further strengthens Polpharma Biologics’ position as a global developer and manufacturer of complex biologic medicines.
The company has continued investing in advanced biologics manufacturing capabilities while expanding its pipeline across multiple therapeutic areas.
PB016 represents another important step in Polpharma Biologics’ strategy to deliver affordable biosimilar therapies that meet stringent international regulatory standards.
As regulatory reviews continue in both the United States and Europe, the company remains focused on working closely with health authorities to support the evaluation process. If approved, PB016 could become an important new biosimilar option for adults living with moderately to severely active ulcerative colitis and Crohn’s disease, helping expand access to effective biologic treatment while supporting more sustainable healthcare systems worldwide.
About Vedolizumab
Vedolizumab (PB016) is a monoclonal antibody that selectively targets the α4β7 integrin, reducing gastrointestinal inflammation by inhibiting the migration of lymphocytes into the gut.1
It is used in the treatment of moderately to severely active ulcerative colitis and Crohn’s disease, chronic inflammatory diseases that can significantly impact patients’ quality of life. Vedolizumab is administered by intravenous infusion.
About Polpharma Biologics International AG
Polpharma Biologics International AG orchestrates the development and commercialization of high-quality biosimilar solutions across key therapeutic areas, including immunology and inflammation, ophthalmology, and hematology. Through close collaboration with trusted CDMOs and commercial partners, Polpharma Biologics delivers end-to-end biosimilar programs designed to ensure efficient progression from concept to launch.
Polpharma Biologics International AG provides integrated program leadership and orchestration across the full biosimilar lifecycle, drawing on deep expertise in program leadership, regulatory strategy, CMC integration, device development, clinical oversight, and quality assurance. With a robust and expanding pipeline spanning multiple programs at various stages of development, the company is committed to accelerating access to high-quality biopharmaceutical therapies worldwide.