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This is the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was passed as part of the Affordable Healthcare Act. But Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes.
Out of the 13 approved interchangeable biosimilars in the past, nine were approved without additional switching study data, the FDA said. KEY QUOTES "Both biosimilars and interchangeable ...
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product.
The FDA approved two interchangeable biosimilars to treat macular degeneration. The biosimilars work the same way as Eylea which prevents abnormal blood vessel growth in the eye and helps preserve ...
Within the United States, the Patient Protection and Affordable Care Act of 2010 created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product.
The U.S. Food and Drug Administration is holding a two-day public hearing to start the process of creating an abbreviated approval procedure for so-called biosimilar and interchangeable biological ...
In July 2021, insulin glargine-yfgn (Semglee) was approved for medical use in the United States as the first interchangeable biosimilar of Lantus. [12] The FDA granted approval of Semglee to Mylan Pharmaceuticals. [12]
The agency approved Biocon Biologics' Yesafili as well as Samsung Bioepis and Biogen's Opuviz, while also allowing interchangeability, or the drug's substitution with biosimilars without the need ...