On Monday, Polpharma Biologics announced that it has randomized the first patients in its phase 3 study of PB006, a proposed natalizumab biosimilar, and patients have begun to receive the study medication.
On Monday, Polpharma Biologics announced that it has randomized the first patients in its phase 3 study of PB006, a proposed natalizumab biosimilar, and patients have begun to receive the study medication.
The phase 3 clinical trial is being conducted in 7 countries in Europe and elsewhere. The first participants were enrolled in a site in Poland.
Natalizumab (Tysabri) is a disease-modifying therapy being used to treat relapsing-remitting multiple sclerosis (MS) as well as Crohn disease. The monoclonal antibody is a selective adhesion molecule inhibitor that binds to α4-integrin.
The proposed biosimilar is being developed by the Poland-based Polpharma and will, if eventually authorized, be commercialized by Sandoz, which the companies announced in September 2019.
The multicenter, randomized, parallel arm, double-blind study of the proposed biosimilar will enroll approximately 260 patients with relapsing-remitting MS who will be randomized to receive 12 doses, every 4 weeks, of either PB006 or the reference natalizumab.
The primary outcome measure of the study is the cumulative number of new active lesions from baseline to week 24. Brain magnetic resonance imaging will be performed at study sites to assess the number of new lesions per patient.
Secondary outcomes include the cumulative number of new active lesions at week 48, a comparison of annualized relapse rates at weeks 24 and 48, the number of persistent lesions at weeks 24 and 48, and evaluations of safety and immunogenicity, among others.
The study is expected to be completed in August 2021.
In addition to its natalizumab biosimilar, Polpharma also developed, together with partner Bioeq, a ranibizumab biosimilar (FYB201) to which Coherus BioSciences recently acquired rights. The drug maker is also in technical development phases with proposed biosimilars of ustekinumab (Stelara), vedolizumab (Entyvio), and 3 undisclosed molecules targeting oncology indications.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
BioRationality: Commemorating the 15th Anniversary of the BPCIA
April 8th 2025Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
BioRationality: How Developers Can Expand Their Monoclonal Antibody Biosimilar Portfolio
March 24th 2025Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.