FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” FDA borrowed this definition from 21 C.F.R.

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Biosimilars Dosage 59

PharmaShots

JUNE 28, 2023

In 2009, Pfizer acquired Wyeth thus seeking the rights to Enbrel. Some of the alternative drugs for Enbrel include: Enbrel’s Biosimilars6 As Enbrel has a long journey in the market it is already facing competition from biosimilars in the US and other countries. Enbrel biosimilars Gabionline.net Centerforbiosimilars.com 7.

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Biosimilars Insurance Coverage and Processing Dosage Compounding 40

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. It acts as a mobilization agent and should be injected subcutaneously with dosage depending on body weight. As of now, there are no the US FDA approved biosimilars available for Actemra.

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Biosimilars Diabetes Chemotherapy Immunity 49