List of USFDA approved Biosimilar [till date]
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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
Mylan settles trastuzumab patent litigation with Genentech and Roche
Development of trastuzumab The drug was first discovered by scientists including Dr. Axel Ullrich and Dr. H. Michael Shepard at UCLA’s Jonsson Comprehensive... Read More
USFDA Biosimilar Approval : 4 Biosimilar total and 3 new approval of biosimilar in 2016
Posted on06 Jan 2017
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Tilldate there are 4 Biosimilar approved in US. In 2015, USFDA approved first Biosimilar In year 2016, there are 3 new biosimilar... Read More