Emergent BioSolutions Receives BioThrax Approval

Emergent BioSolutions said that the Paul-Ehrlich-Institut (PEI), the regulatory agency under the German Federal Ministry of Health, has approved the company’s large-scale manufacturing facility, Building 55, located in Lansing, MI. This approval allows Emergent to market BioThrax (Anthrax Vaccine Adsorbed) manufactured in Building 55 in Germany. BioThrax is the only anthrax vaccine licensed by the PEI for pre-exposure prophylaxis of anthrax disease. It is also the only anthrax vaccine licensed by the U.S. Food and Drug Administration (FDA) for both pre-exposure prophylaxis and post-exposure prophylaxis of anthrax disease.

"Emergent is pleased with PEI approval of our large-scale manufacturing facility, Building 55, which comes on the heels of Building 55 licensure by the FDA," said Adam Havey, executive vice president and president, biodefense division of Emergent BioSolutions. "With this regulatory milestone, the company believes it is well-positioned to pursue BioThrax licensure across targeted countries within the EU. This is in line with our strategy and supports our efforts to expand international sales as well as maximize utilization of our manufacturing infrastructure and capabilities."   

In 2013, Germany became the first country in the EU to approve the sale of BioThrax through PEI market authorization of BioThrax manufactured in Building 12, the company’s original manufacturing facility. With the approval of Building 55, Emergent has expanded its capacity to supply BioThrax to a broader customer base while fulfilling U.S. government requirements. Building 55 is designed to manufacture approximately 20 million to 25 million doses of BioThrax annually. Since receiving FDA licensure in August 2016, the company has begun to supply BioThrax manufactured in Building 55 to the U.S. Strategic National Stockpile.