NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

The evolving on FDAs stance on biosimilars.

BioRationality: A Dr Sarfaraz Niazi Column—FDA Discloses Changes to Drug Review Process, Biosimilar Licensing
Jan 30, 2023
By Sarfaraz K. Niazi, PhD

https://www.centerforbiosimilars.com/view/biorationality-a-dr-sarfaraz-niazi-column-fda-discloses-changes-to-drug-review-process-biosimilar-licensing

Expediting Biosimilar Development

Bringing more drug competition to the market and addressing the high cost of medicines is a priority for the FDA and the HHS, an effort exemplified by the Drug Competition Action Plan in2017 and the Biosimilars Action Plan in 2018. These plans outlined concrete steps the FDA would take to remove barriers to biosimilars and generic drug development, including prioritizing biosimilar applied research projects.

https://www.researchgate.net/publication/370539818_Functional_Biosimilarity_to_Replace_Clinical_Efficacy_Testing_of_mAb_Biosimilars_Advancing_the_FDA_Perspective

Functional Biosimilarity to Replace Clinical Efficacy Testing of mAb Biosimilars: Advancing the FDA Perspective
April 2023
Sarfaraz K Niazi.

The FDA has concluded that a biosimilar candidate capable of demonstrating pharmacodynamic biomarkers in a healthy subject need not be tested for clinical efficacy in patients, regardless of if the biomarker correlates with clinical response.

https://pubmed.ncbi.nlm.nih.gov/38004421/

A Critical Analysis of the FDA's Omics-Driven Pharmacodynamic Biomarkers to Establish Biosimilarity
Sarfaraz K Niazi. Pharmaceuticals (Basel). 2023.

Demonstrating biosimilarity entails comprehensive analytical assessment, clinical pharmacology profiling, and efficacy testing in patients for at least one medical indication, as required by the U.S. Biologics Price Competition and Innovation Act (BPCIA). The efficacy testing can be waived if the drug has known pharmacodynamic (PD) markers, leaving most therapeutic proteins out of this concession. To overcome this, the FDA suggests that biosimilar developers discover PD biomarkers using omics technologies such as proteomics, glycomics, transcriptomics, genomics, epigenomics, and metabolomics. This approach is redundant since the mode-action-action biomarkers of approved therapeutic proteins are already available, as compiled in this paper for the first time. Other potential biomarkers are receptor binding and pharmacokinetic profiling, which can be made more relevant to ensure biosimilarity without requiring biosimilar developers to conduct extensive research, for which they are rarely qualified.