Biosimilars Flashcards
What are biologics?
produced using living thing/cell
List the stages of biologic production
modify host cells
grow cells
extract, refold, purify
formulate to stable finished drug product
What is a biosimilar?
a copy of commercially available biopharm that is no longer protected by patent
they are similar (not identical, has small allowed variability)
Why do you need biosimilars?
lowering health care cost
more treatment options
How are biosimilars developed?
involve reverse engineering
What is CQA?
critical quality attributes
needs to have certain characteristics in order to be considered biosimilars
which related system is primary structure associated with?
product related
What is different about biosimilars for antibodies?
it can only be established through evaluation of the biosimilar in active comparator clinical trials and experiments with the reference product
What is the major goal of tests for biosimilars?
to determine similarity
- major part is physiochemical characterization
What is the major goal of test for the orginator?
to determine the clinical effect
- major part is clinical trials
List the steps of creating a biosimilar
characterization of reference product
cell line creation
cultivation and production
isolation and purification
formulation, fill and finish
What are interchangeables?
An interchangeable product may be substituted for the reference product without the involvement of the prescriber
What is a small molecule biosimilar called?
generic drug
What are non comparables?
copies of licensed biologic medicines that are
marketed in some countries, but have not followed the rigorous regulatory pathways required for biosimilars
What are cautions when it comes to non-comparables?
the products may have clinically significant differences in quality, efficacy, and safety compared with their reference products
also have shown to be reduced biological potency or higher rates of adverse events
