Biotest AG announced that Biotest Pharmaceuticals Corporation (BPC) has received FDA approval for BIVIGAM™ for the treatment of patients with Primary Humoral Immunodeficiency (PI). BIVIGAM is the first polyspecific intravenous immune globulin manufactured in the U.S. by BPC at its Boca Raton facility. This product is being produced for patients in the United States, and the company plans to begin commercial shipments shortly.
Prof. Dr. Gregor Schulz, CEO of Biotest AG, said: “Biotest has made a significant commitment in the U.S. to bring a new immune globulin to individuals with primary immunodeficiency. We have invested over $50 million to create a state-of-the-art facility and have expanded our U.S. capabilities from plasma collection to protein purification and product distribution. BPC will eventually produce up to 1.5 million grams (= 1.5 tons) of BIVIGAM in the U.S. facility. We look forward to providing this therapy to patients in the U.S. This will be another milestone in Biotest’s long legacy of providing immune globulin products to patients around the globe.”
The U.S. IVIG market is the largest in the world and Biotest’s entry into this market fulfills the company’s longstanding vision of being a significant global participant. Biotest formed BPC as a U.S. subsidiary in 2007, with the purchase of Nabi Biopharmaceuticals’ biologics strategic business unit, which included a plasma protein plant and plasma collection centers. Today’s approval represents a sales potential of $100 million for BPC.