Celltrion to Produce Biosimilars in the United States

Korean drug maker Celltrion has entered into a contract manufacturing organization (CMO) agreement with Baxter BioPharma Solutions for the production of its biosimilars in the United States.

Korea Biomedical Review reports that Celltrion’s contract with Baxter is intended to increase the stable supply of biosimilar products for the US marketplace. First to be produced by Baxter is Celltrion’s infliximab (Remicade) biosimilar, which has been approved by the FDA and is marketed as Inflectra in the United States. Celltrion has also submitted Biologics License Applications to the FDA for its rituximab (Rituxan, MabThera) and trastuzumab (Herceptin) biosimilars. If these 2 drugs are approved, Baxter will produce finished products of both biosimilars for the US market.

“With the latest agreement, Celltrion has secured a local drug producer in the [United States], the world’s biggest biopharmaceutical market,” a Celltrion official told The Korea Herald. “The firm expects to meet local demand in a more flexible manner.”

The news that Celltrion will manufacture Inflectra in the US follows the September release of a Form 483 issued by the FDA, noting 12 observations made while the agency inspected Celltion’s Incheon, Republic of Korea facility. Among the concerns identified were issues with vial stoppers, deficient environmental monitoring in aseptic processing areas, and inadequate procedures to prevent microbiological contamination. When the heavily redacted form was released, some analysts suggested that the FDA’s observations could be one factor in explaining the slow uptake of Inflectra in the United States.

Celltrion also recently announced that it has dropped its plans to build a third manufacturing facility in the Republic of Korea amid escalating political tensions with North Korea. Celltrion’s CEO, Seo Jun-jin, told shareholders in a September meeting that the company would make a decision concerning the location of the company’s first overseas factory by early next year.