Fresenius Kabi’s vedolizumab biosimilar PB016 enters FDA and EMA review, while its rituximab biosimilar gains U.S. FDA approval, expanding access to biologics.
Written By: Kirti Kumbhar, M.Pharm (QA)
Reviewed By: Pharmacally Editorial Team
Fresenius Kabi has achieved two important regulatory milestones within days, strengthening its global biosimilars portfolio across autoimmune diseases and oncology. The company announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory applications for review of PB016, its proposed intravenous (IV) vedolizumab biosimilar referencing Entyvio® (vedolizumab). Shortly thereafter, the FDA approved the company’s rituximab biosimilar for the U.S. market, further expanding its biosimilar offerings in immunology and oncology.
FDA and EMA Accept PB016 for Regulatory Review
The FDA accepted Fresenius Kabi’s Biologics License Application (BLA), while the EMA validated the Marketing Authorisation Application (MAA) for PB016. The proposed biosimilar is being developed by Polpharma Biologics, with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East and North Africa, subject to regulatory approval.
The regulatory submissions are supported by a comprehensive biosimilar development program designed to demonstrate that PB016 is highly similar to the reference product through analytical, non-clinical, pharmacokinetic, and clinical evaluations, consistent with global biosimilar approval requirements.
Clinical Program Supports Biosimilarity
The clinical evidence for PB016 includes a Phase 1 study in healthy volunteers and a Phase 3 clinical trial (NCT05771155) in patients with moderately to severely active ulcerative colitis. Together, these studies contribute to the totality of evidence required to establish biosimilarity to the reference biologic.
Vedolizumab is a gut-selective monoclonal antibody that targets the α4β7 integrin, preventing inflammatory lymphocytes from migrating into gastrointestinal tissue. It is approved for adults with moderately to severely active ulcerative colitis and Crohn’s disease, two chronic forms of inflammatory bowel disease (IBD) that affect an estimated 2.4 million people in the United States and approximately 2.5 to 3 million people across Europe.
If approved, PB016 could expand treatment options and improve access to biologic therapy for patients living with IBD by providing a high-quality, lower-cost alternative to the reference product.
FDA Approves Rituximab Biosimilar for the U.S.
Building on the momentum of the vedolizumab regulatory submissions, Fresenius Kabi also announced FDA approval of its rituximab biosimilar, developed by Dr. Reddy’s Laboratories as a biosimilar to Rituxan® (rituximab). Under an exclusive commercialization agreement, Dr. Reddy’s developed, manufactured, and submitted the product, while Fresenius Kabi holds exclusive U.S. commercialization rights.
Rituximab is a CD20-directed monoclonal antibody indicated for multiple hematologic malignancies and autoimmune diseases, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA). The FDA approval was based on the totality of evidence demonstrating high similarity to the reference product, with no clinically meaningful differences in quality, safety, or efficacy.
Strengthening the Biosimilars Portfolio
Together, the regulatory review of PB016 and the FDA approval of the rituximab biosimilar represent important advances in Fresenius Kabi’s FutureFresenius strategy, which identifies biopharmaceuticals as a key growth area. The two milestones strengthen the company’s presence in both autoimmune diseases and oncology while reinforcing its integrated capabilities across biosimilar development, manufacturing, and global commercialization.
As biosimilars continue to improve patient access to biologic medicines, these regulatory achievements position Fresenius Kabi to further expand its global portfolio of high-quality, affordable treatment options for patients with chronic inflammatory diseases and cancer.
Reference
Fresenius Announces FDA Approval of Rituximab Biosimilar for the U.S. Market
Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate
About the Writer
Kirti Kumbhar (LinkedIn) is an MPharm graduate with experience in Quality Assurance at Lupin Limited and a strong interest in clinical research, regulatory affairs, and Trial Master File (TMF) management. She has developed knowledge of regulatory documentation, quality systems, compliance, and healthcare research through her professional experience. Passionate about clinical development and continuous learning, Kirti is committed to supporting high-quality healthcare documentation, regulatory excellence, and research-driven healthcare advancements.