Biosimilars

Question 1

Types of biologics

Answer 1

Hormones
Blood products
Cytokines
Growth factors
Monoclonal antibodies
Vaccines
Gene and cellular therapies
Fusion proteins

Question 2

What is a biologic?

Answer 2

Derived from living sources
Procured from living organisms

Question 3

Describe the size of biologics

Answer 3

They are large and vary in size and complexity

Question 4

How are biologics different from small molecules?

Answer 4

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

Question 5

What is a biosimilar?

Answer 5

A “copy” of a commercially available biopharmaceutics l (original product) that is no inter protected by patent

Question 6

What must be done for biosimilars?

Answer 6

Rigorous analytical and clinical assessment, in comparison to its reference product

Question 7

Can there be differences in biosimilars from original product?

Answer 7

Ther can be minor differences due to their complex nature and production methods.

Question 8

What must be the same for biosimilars?

Answer 8

Dose(strength), and administration mode
Efficacy and safety must be similar

Question 9

Why do we need biosimilars?

Answer 9

Lower costs
More treatment options for the patients

Question 10

How are biosimilars developed?

Answer 10

Use reverse engineering
Develope specific cell line and biological process
Characterize biosimilar candidate and identify CQAs
Evaluate similarity to originator

Question 11

Process customization

Answer 11

**

Question 12

What is CQA?

Answer 12

Critical quality attributes
____

Question 13

How are biosimilars understood?

Answer 13

Integration of data
Combined data from ~45 different methods

Question 14

Extensive analytical characterization is used*

Answer 14

Make up a question on this

Question 15

What is primary structure?

Answer 15

**

Question 16

What needs to be done for making antibodies?

Answer 16

Need to do checking in clinical trials

Question 17

What is the goal of development for biosimilar?

Answer 17

To demonstrate biosimilarity

Question 18

What is the main goal for the originator product?

Answer 18

To establish safety and efficacy of a new product through clinical trials
Determine clinical effect

Question 19

What are the sources of variation between manufacturers for biosimilar production?

Answer 19

Gene sequence
recombinant DNA plasmids - different vector
Which host cell is uses
Cell expansion if different cell line
Different bioreactor conditions

Question 20

What are the sources of variation between manufacturers for biosimilar formulation?

Answer 20

Different operating conditions
Different binding and elution conditions
Different filter supplier
Different methods, reagents and reference standards
Different suppliers of excipients

Question 21

What is check in step 1 - characterization of reference product?

Answer 21

Primary structure
Higher order structure
Stability
Biological function
Receptor binding and immuno-chemical properties
General properties, excipients

Question 22

What is step 2?

Answer 22

Cell line creation

Question 23

What is step 3?

Answer 23

Cultivation and production

Question 24

What is step 4?

Answer 24

Isolation and purification

Question 25

What is step 5?

Answer 25

Formulation, fill and finish
3rd checkpoint

Question 26

What happens post-approval?

Answer 26

There is a pharmacovigilance ensures clinical safety and that product is doing well

Question 27

What are interchangeables?

Answer 27

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.

Question 28

How do we regulate biosimilars in Canada?

Answer 28

**

Question 29

What are not biosimilars?

Answer 29

Second-generation (or biobetter)
Generic drugs - smaller molecules

Question 30

Does a biosimilar take longer to develop or a new biologic?

Answer 30

A new biologic takes longer

Question 31

What are non-comparables?

Answer 31

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.