Grifols’ Biotest Wins First German Approval for Fibrinogen Concentrate Prufibry
Grifols SA's subsidiary Biotest has received the first German approval for its fibrinogen concentrate, Prufibry®, from the Paul-Ehrlich-Institut. This product is intended for treating congenital and acquired fibrinogen deficiency and is expected to be available in Germany by the end of 2025, with Austria and Spain following in 2026. Grifols has also submitted a biologic license application for the therapy in the U.S., with a decision expected by year-end. This approval enhances Grifols' bleeding management portfolio, providing new treatment options for patients at risk of critical bleeding.
Grifols SA has announced that its subsidiary Biotest has received the first regulatory approval for its fibrinogen concentrate, Prufibry®, from the German authority Paul-Ehrlich-Institut. The product is approved for the treatment of both congenital and acquired fibrinogen deficiency and is expected to be available to patients in Germany by the end of 2025. Austria and Spain are anticipated to follow with approvals in 2026. Additionally, Grifols has submitted a biologic license application for the same therapy in the United States, with a regulatory decision expected by the end of the year. This approval expands Grifols’ and Biotest’s bleeding management portfolio, offering new therapeutic options for patients facing critical bleeding risks. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Grifols SA published the original content used to generate this news brief on November 13, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
