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.

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