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In March 2020, most protein products that were approved as drug products (including every insulin currently on the market as of December 2019) are scheduled to open up to biosimilar and interchangeable competition in the United States. [16]
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.
"Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product," said Sarah Yim ...
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 ...
Tuesday, the FDA approved Amgen Inc (NASDAQ:AMGN) Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca Plc’s (NASDAQ:AZN) Soliris (eculizumab) to treat certain rare ...
Part of the government's signatory Patient Protection and Affordable Care Act, it has created a pathway for fast-track licensure for biological products that are shown to be "biosimilar" to, or "interchangeable" with, an approved biological product. One inspiration for the act was that the patents for many biologic drugs will expire in the next ...
Amgen's drug will be marketed under the name Bkemv. Biosimilars are close copies of complex biological drugs. In 2022, the company said that Bkemv met the main goal of a late stage study, where ...