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Hyrimoz News
Select Strengths of Sandoz Biosimilar Hyrimoz Granted Interchangeability by FDA
May 08, 2024 – On April 5, 2024, the US Food and Drug Administration (FDA) approved Sandoz’s supplemental biologics license application (sBLA) seeking interchangeability to include the 10 mg/0.1 mL, ...
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
October 26, 2023 – Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and...
Sandoz Receives US FDA Approval for Biosimilar Hyrimoz (adalimumab-adaz) High-Concentration Formulation
Biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) approved for seven indications of reference medicine Humira®* With this approval, Sandoz adalimumab HCF biosimilar will o...
FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira
November 18, 2019 - Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Abrilada™ (adalimumab-afzb), as a biosimilar to Humira® (a...
FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira
Holzkirchen, Germany, October 31, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its...
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