- The reintroduction of an intravenous immune globulin product to the U.S. market could help ease a supply crunch that's forced some hospitals and clinics to ration treatment with the plasma-derived therapies.
- On Thursday, ADMA Biologics announced the commercial relaunch and first sales of its immune globulin Bivigam, which is approved to treat patients suffering from any one of a family of inherited immune deficiencies that increase infection risks.
- Supply of Bivigam, first approved in 2012, was curtailed by since-resolved manufacturing issues at a Boca Raton, Florida-based facility that ADMA acquired in a 2017 deal with Biotest Pharmaceuticals. In May, the Food and Drug Administration approved a supplemental application permitting ADMA to reintroduce Bivigam commercially.
Shortages of immune globulin, which consists of antibodies harvested from blood plasma, have persisted since late last year, when supply of products made by Takeda and Bio Products Lab became limited.
Since then, in April, a second Takeda drug has gone into shortage, putting pressure on hospitals and infusion clinics which treat the tens of thousands of Americans who have immune deficiency diseases.
In some cases, hospitals have resorted to suspending or canceling treatment, according to an August report from The Wall Street Journal.
The FDA recommends providers and hospitals facing supply shortages create "evidence-based" frameworks to decide who to treat. The agency is also encouraging systems with contracts for only one immune globulin product to consider adding a second.
Twenty-one immune globulin products, both intravenous and subcutaneous, are currently approved, including drugs made by Takeda, Pfizer and CSL Behring.
Takeda's presence in the market comes by way of its $62 billion acquisition of Shire, which sold Gammagard Liquid and Cuvitru. The biotech was working to expand its manufacturing capacity, opening a new facility in Stanton Springs, Georgia last fall.
With Bivigam now back on the market, ADMA sells two — including its recently approved Asceniv, an intravenous immune globulin.
"The manufacturing, testing and final packaging for a complex biologic product like Bivigam typically takes anywhere from six to nine months and sometimes longer to deliver to customers and end users," said ADMA CEO Adam Grossman in a statement.
"ADMA believes it is doing everything in its power to ramp up production to a steady state to ensure the continuity of care for patients, while continuing to operate in accordance with the FDA's quality regulations and expectations."
ADMA is making Bivigam available through distributor BioCare SD.