The announcement was made through the office of governor of Charleston, West Virginia, Jim Justice, where it was revealed the South Korean company had secured a lease with West Virginia University to build a facility in Morgantown.
Phase one of the project will see Undbio invest $100m (€90m) in the first three years, which will see the creation of 200 jobs.
According to the state, once the first phase of the projected in completed, which will include securing US Food and Drug Administration (FDA) approval for Undbio’s product, the company plans to expand further and create additional employment in the area.
During the announcement, which was streamed live, it was revealed that the plans are for work on the facility to commence in September or October of this year. It was also noted at the event that the total employee count is expected to scale up to 600 positions.
Undbio CEO, Caleb Jun, noted at the announcement that as part of the move to create the manufacturing base, the company would also create research and internship links with West Virginia University, as well as conducting clinical trials and post-marketing studies alongside the university.
Undbio’s portfolio of insulin products includes recombinant human insulin, insulin glargine, and insulin lispro. The company also markets drug device combinations focused on diabetes, such as insulin pumps, and continuous blood glucose monitoring systems.
Outside of insulin, Undbio also holds several biosimilar products in its portfolio, including adalimumab and bevacizumab, which are monoclonal antibodies and are known by the branded products, Humira and Avastin, respectively.
Undbio’s move to create manufacturing capacity in the US arrives as the market for biosimilar insulin has opened up. In 2020, the FDA allowed manufacturers to apply to the agency for the approval of biosimilar insulin products, with similar action taking place in Europe. The first insulin biosimilar gained approval on the US market in 2021.
It is estimated that the cost savings from biosimilar insulin will be approximately $54bn between the years 2017 to 2026. However, due to the cost and complexity of manufacturing insulin, the market for developing and commercializing has proven to be a limited one to date.
Earlier this year, Biocon was knocked back in its efforts to market an insulin product through its biologics division, as the FDA requested additional data and corrective measures to be taken at its manufacturing facilities in India.