Biosimilars, Documentation and White Paper

Quality by design with a focus on biosimilars

Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Practising QbD in biosimilar product development. For biosimilars, however, this process is slightly more complex.

FDA’s Summer Plans May Include LDT Rulemaking

FDA Law Blog: Biosimilars

JUNE 19, 2023

And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds. See , e.g. , ACLA White Paper on LDTs here. Rulemaking avoids the twin problems of dependency on action by Congress and the legal weakness of imposing substantive legal requirements through guidance.

Documentation

A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House

FDA Law Blog: Biosimilars

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. Biotechnology and Biomanufacturing; Harnessing Research and Development to Further Societal Goals.”

Documentation

Pharmacist Digest

Quality by design with a focus on biosimilars

FDA’s Summer Plans May Include LDT Rulemaking

A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House

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