2001, Biosimilars and Drug Development

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2001

Biosimilars

Drug Development

Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

JULY 4, 2024

4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. 2012/1916).

Drug Development

Drug Development Biosimilars Documentation Labelling

FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered

FDA Law Blog: Biosimilars

APRIL 23, 2023

Outstanding Questions This Draft Guidance expands on the 2001 ICH E10 guidance (Choice of Control Group and Related Issues in Clinical Trials) and does a fairly thorough job describing the limitations and challenges facing sponsors seeking to use an externally controlled trial, particularly using RWD.

Documentation

Documentation Drug Development

Pharmacist Digest

Botanical drugs – what is the best way forward for regulatory and market approval?

FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered

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