Biosimilars Flashcards
Types of biologics
Hormones
Blood products
Cytokines
Growth factors
Monoclonal antibodies
Vaccines
Gene and cellular therapies
Fusion proteins
What is a biologic?
Derived from living sources
Procured from living organisms
Describe the size of biologics
They are large and vary in size and complexity
How are biologics different from small molecules?
Small molecules use chemical synthesis and are a single substance - very easy to produce and MOA is ambiguous
Biologics are produced using living things - sometimes need to be glycosylated - MOA is very clearly defined
What is a biosimilar?
A “copy” of a commercially available biopharmaceutics l (original product) that is no inter protected by patent
What must be done for biosimilars?
Rigorous analytical and clinical assessment, in comparison to its reference product
Can there be differences in biosimilars from original product?
Ther can be minor differences due to their complex nature and production methods.
What must be the same for biosimilars?
Dose(strength), and administration mode
Efficacy and safety must be similar
Why do we need biosimilars?
Lower costs
More treatment options for the patients
How are biosimilars developed?
Use reverse engineering
Develope specific cell line and biological process
Characterize biosimilar candidate and identify CQAs
Evaluate similarity to originator
Process customization
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What is CQA?
Critical quality attributes
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How are biosimilars understood?
Integration of data
Combined data from ~45 different methods
Extensive analytical characterization is used*
Make up a question on this
What is primary structure?
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What needs to be done for making antibodies?
Need to do checking in clinical trials
What is the goal of development for biosimilar?
To demonstrate biosimilarity
What is the main goal for the originator product?
To establish safety and efficacy of a new product through clinical trials
Determine clinical effect
What are the sources of variation between manufacturers for biosimilar production?
Gene sequence
recombinant DNA plasmids - different vector
Which host cell is uses
Cell expansion if different cell line
Different bioreactor conditions
What are the sources of variation between manufacturers for biosimilar formulation?
Different operating conditions
Different binding and elution conditions
Different filter supplier
Different methods, reagents and reference standards
Different suppliers of excipients
What is check in step 1 - characterization of reference product?
Primary structure
Higher order structure
Stability
Biological function
Receptor binding and immuno-chemical properties
General properties, excipients
What is step 2?
Cell line creation
What is step 3?
Cultivation and production
What is step 4?
Isolation and purification
What is step 5?
Formulation, fill and finish
3rd checkpoint
What happens post-approval?
There is a pharmacovigilance ensures clinical safety and that product is doing well
What are interchangeables?
Product that may be substituted for the reference product without the involvement of the prescriber
In addition to being biosimilar, they meet additional requirements based on further evaluation and testing of the product.
How do we regulate biosimilars in Canada?
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What are not biosimilars?
Second-generation (or biobetter)
Generic drugs - smaller molecules
Does a biosimilar take longer to develop or a new biologic?
A new biologic takes longer
What are non-comparables?
Also known as “bio copies”, intended copies or non regulated biologics that are copies of licensed biologic medicines that are marketed in some countries, but have not followed the rigorous regulatory pathways required for biosimilars.
