A Profile of a Lesser-Known Player in the Biosimilar Space: Polpharma Biologics

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.

Polpharma Biologics

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).

A Profile on Lesser-Known Player in the Biosimilar Space: Nichi-Iko Pharmaceutical Company

On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies that have 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 Japanese company, Nichi-Iko Pharmaceutical Company, Ltd.

First established in 1965, Nichi-Iko Pharmaceutical Company has been operating under its current name since 2005. It is based in Tokyo and Toyama, Japan. Historically, Nichi-Iko has produced generic pharmaceutical products for the Japanese and Asian markets. It has grown over the years through mergers and acquisitions, including the purchase of Schaumberg, Illinois–headquartered Sagent Pharmaceuticals in 2016. Sagent produces a host of generic drugs for the US market. Nichi-Iko also has a strategic alliance agreement in place with Eisai Co, Ltd.

Why you may be hearing more about this company: Nichi-Iko’s mission statement is “…to provide value-added, high-quality generic products…” but it has also ventured into the biosimilar marketplace. The company received an approval in Japan for its infliximab biosimilar (NI-071). A phase 3 trial of this product is currently being completed (completion date slated for February 2019) in US patients with rheumatoid arthritis, and the company hopes to file a 351(k) application for approval with the Food and Drug Administration later this year. Additionally, Nichi-Iko has filed for Japanese approval for its etanercept biosimilar, and is involved in a phase 1 trial for a trastuzumab biosimilar targeted for the US and EU marketplace. As the agreement with Eisai seems to apply to marketing generics only, Nichi-Iko’s subsidiary Sagent Pharmaceuticals seems to be a logical choice for biosimilar commercialization in the US.