On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies with products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight a European company, Polpharma Biologics. The drug maker has centers in Gdansk and Duchnice, Poland; Utrecht, The Netherlands; and Zurich, Switzerland.
Established in 2013, Polpharma Biologics is a contract development and manufacturing organization that also develops its own biosimilars and biologics. Polpharma has several next-generation biosimilars and innovative therapies in its pipeline. Its CEO is Joerg Windisch, PhD, a 19-year former employee of Sandoz. The organization says on its website, “As biologics continue to advance the treatment of some of the most historically complex conditions, we are leveraging our large molecule capabilities to develop a number of biosimilars-biologic medicines that have no meaningful difference from their reference product in terms of safety and efficacy and are more affordable than the originator drug.”
Why you may be hearing more about this company: Polpharma is preparing a regulatory submission for its lead biosimilar, FYB201 (ranibizumab). The other biosimilar in clinical development is PB006 (natalizumab). Importantly, Polpharma Biologics secured a commercialization agreement with Sandoz for this agent, a biosimilar to Tysabri®. The company has just begun a phase 3 clinical trial, including 260 patients with multiple sclerosis, which is due for completion in August 2021.
In addition, Polpharma’s pipeline includes biosimilars for ustekinumab (Stelara®) and vedolizumab (Entyvio®), both in early stages of development. Polpharma is also interested in developing an innovative biologic agent for the treatment of autoimmune diseases and an immune checkpoint inhibitor (presumably as a cancer therapy).
