Eye on Pharma: Sagent Acquires US Site to Manufacture Nichi-Iko Biosimilars

The Center for Biosimilars Staff

Sagent Pharmaceuticals, a division of Nichi-Iko Pharmaceutical Co Ltd, announced earlier this month that it has purchased an FDA-approved manufacturing site in Raleigh, North Carolina, from Xellia Pharmaceuticals.

Sagent Pharmaceuticals, a division of Nichi-Iko Pharmaceutical Co Ltd, announced earlier this month that it has purchased an FDA-approved manufacturing site in Raleigh, North Carolina, from Xellia Pharmaceuticals.

The site is capable of approving both small-molecule drugs and biologics. While Sagent’s chief executive officer (CEO), Peter Kaemmerer, PhD, said in a statement that while it intends to continue to manufacture some products for Xellia, the acquisition of the Raleigh site “will enable production of lyophilized formulations of our future biosimilar product offerings.”

Yuichi Tamura, president and CEO of Nichi-Iko, said in a statement, “We applaud this acquisition as another big step forward for Nichi-Iko and Sagent, further strengthening our competitiveness and capabilities in the key US market. The acquisition of this manufacturing facility, our first in the [United States], will have an important role as we strive to fulfill our mission of providing value-added, high quality generic products which meet the needs of patients and their families in the global market.”

Nichi-Iko has already begun its foray into biosimilars; the company received approval for its biosimilar infliximab, NI-071, in Japan in 2017, and subsequently began a phase 3 clinical program in the United States with an eye toward eventual FDA approval. The company also disclosed that it has consulted with the FDA concerning a demonstration of interchangeability for the biosimilar with the reference infliximab, Remicade.

Furthermore, in June 2018, the company announced that it had forged a partnership with Lupin for the distribution, promotion, and sale of a proposed etanercept biosimilar, YLB113, in Japan. In the Republic of Korea, Nichi-Iko’s Aprogen affiliate last year completed construction of a biologics production facility to provide a stable supply of biosimilars for the US and Japanese markets.