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Posted On: 10/19/2020 2:51:04 AM
Post# of 149265
Re: Cassandra X #61924
Cassandra,
I looked back at my message and it was a typo. It should have said CDER.
Thank you for pointing that out.
https://en.wikipedia.org/wiki/Center_for_Biol...d_Research
http://www.expedient-solutions.com/workshop/f..._Tacey.pdf
https://www.fda.gov/drugs/new-drugs-fda-cders...ovals-2019
I looked back at my message and it was a typo. It should have said CDER.
Thank you for pointing that out.
Quote:
Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).
https://en.wikipedia.org/wiki/Center_for_Biol...d_Research
http://www.expedient-solutions.com/workshop/f..._Tacey.pdf
Quote:
Zirabev (bevacizumab-bvzr), the second biosimilar to Avastin (bevacizumab). Zirabev is a monoclonal antibody used to prevent the growth of certain types of tumors. It is FDA-approved for the following indications currently approved for U.S.-licensed Avastin: metastatic colorectal cancer; non-squamous non-small cell lung cancer; glioblastoma (cancer originating in the brain); metastatic renal cell carcinoma (a type of kidney cancer that has spread to other parts of the body), and cervical cancer. CDER approved the first Avastin biosimilar, Mvasi (bevacizumab-awwb), in 2017 .
https://www.fda.gov/drugs/new-drugs-fda-cders...ovals-2019
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