What is difference between 351(a) vs. 351(k) pathway?
Posted on13 Sep 2017
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351(a) is the original approval pathway for biologics. It is the pathway for approval of innovator biologics. It is also known as... Read More
What is 351(k) biologics license application (BLA)?
351(k) biologics license application is the biosimilar application process in USFDA. Manufacturers must submit 351(k) biologics license application (BLA) to have a product... Read More
US FDA accepts Sandoz’s proposed biosimilar of rituximab for review
Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, announced that the US Food and Drug Administration (FDA) has... Read More