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.
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.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.