IVIG Manufacturing Process for Bivigam Approved by FDA

ADMA Biologics has received approval from the U.S. Food and Drug Administration (FDA) for its prior approval supplement for Bivigam (immune globulin intravenous [human] 10% liquid), allowing the company to use its optimized intravenous immune globulin (IVIG) manufacturing process and market Bivigam to primary immunodeficiency patients in the U.S.

Bivigam was first approved by FDA in December 2012 and was then marketed by Biotest Pharmaceuticals Corp.; however, Biotest suspended commercial production of Bivigam due to manufacturing and compliance issues. Subsequent to ADMA’s acquisition of the Biotest Therapy Business Unit in June 2017, ADMA resumed production of Bivigam during the fourth quarter of 2017, successfully manufacturing three conformance lots using the company’s optimized IVIG manufacturing process. ADMA anticipates the relaunch of Bivigam for commercial sale during the second half of 2019.

“We are pleased to reintroduce Bivigam into the market, where demand for IVIG therapy continues to outpace supply,” said Adam Grossman, president and chief executive officer of ADMA. “The $6 billion U.S. market for IVIG continues to grow, and the relaunch of Bivigam can help to alleviate a portion of the tight supply for this important patient population where dependable and consistent supply of IVIG is critical to patients’ well-being.”