Monthly Archives: %sNovember 2015

Proposed Changes to Immunogenicity Requirements for Biopharmaceuticals (Part 1)

In light of experience, since the original guidance document was published in 2006, there are a number of changes under consideration in the draft guidance document ‘Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins’[i].

Broadly these include:

More specific requirements for immunogenicity assays
Investigation into the clinical significance of immunogenicity
Risk-based approach to immunogenicity with requirements for both […]

CMC Development of Biosimilars


In order to establish biosimilarity to the innovator biopharmaceutical (reference product) it is necessary for the product to be highly comparable to the reference product from the region in which approval is ultimately sought.

A stepwise approach is recommended by firstly establishing that the CMC aspects are highly comparable to the reference product. For example:

The […]

By |November 26th, 2015|Uncategorized|0 Comments