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. Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

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Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.

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Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Novel drug products are defined as products that have never been approved for any indication. The FDA also refers to novel products as “New Molecular Entities,” or NMEs.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

The mostly redacted, then publicly available letter accompanying the basis for the recommendation stated that FDA was making a recommendation about marijuana, referring to botanical cannabis ( Cannabis sativa L.) within the CSA’s definition of “marihuana” or “marijuana” based on FDA’s eight factor analysis. 21 U.S.C. §

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The Pharma Data

APRIL 27, 2021

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7) (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 7).

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Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

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Agency IQ

DECEMBER 1, 2023

January 2024 Amendments to Patent Term Restoration (Proposed Rule) FDA is proposing to amend its Patent Term Restoration regulations to identify the effective date of approval for scheduled drugs, to define when the 60-day period referred to in 35 U.S.C. fit in this definition.

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