Biosimilars and Generics Flashcards Preview

Quality Use of Medicines > Biosimilars and Generics > Flashcards

Flashcards in Biosimilars and Generics Deck (17)
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1
Q

What is a Generic Medication?

A

Before generic medicines we had ‘originator’ products which are medicines that are new and have been approved for marketing in Australia

Once the patent expires, ‘generic’ products can be marketed

2
Q

A generic product is a medicine that, in comparison to the originator product:

A

Has the same quantitative composition of therapeutically active substances

Has the same pharmaceutical form

Is bioequivalent

Have the same safety and efficacy properties

3
Q

What is Biological Medicine?

A

A medicine derived from a living system that may be either sourced from nature or produced using recombinant techniques

4
Q

What are Biosimilars?

A

A biological medicine that contains a version of the active substance of an already authorised original biologic (reference product [originator]) that is similar in terms of quality, biological activity, tolerability and efficacy

Although highly similar, not identical versions of an already registered biological medicine

5
Q

Why can’t we make exact copies of the proteins that are used as biological agent drugs?

A

Complex structures

6
Q

What are Glycoproteins?

A

Protein with a sugar attached

7
Q

What does Glycosylation affect?

A

Solubility, stability (susceptibility to proteolysis), antigenicity and orientation (structure of protein)

8
Q

What are the 2 Categories of Glycoproteins?

A

N-Glycans

O-Glycosylation

9
Q

Categories of Glycoproteins: What are N-glycans?

A

Covalently attached to proteins at the amide of asparagine

10
Q

Categories of Glycoproteins: What is O-glycosylation?

A

Glycan is attached to the side chains of serine or threonine residues

11
Q

Where does Glycosylation Occur?

A

Glycosylation occurs in endoplasmic reticulum and golgi apparatus - regulated by >200 enzymes

12
Q

Most monoclonal antibodies are ____ sub-types?

A

IgG

13
Q

What is the Molecular Weight of IgG?

A

150kDa

14
Q

How many Amino Acids does IgG contain?

A

Contains over 1300 amino acids

15
Q

How many Amino Acid Chains make up a single IgG molecule?

A

4 individual amino acid chains that make up a single IgG molecules

2 heavy chains (50kDa each) and 2 light chains (25 kDa each)

16 disulfide bridges

Heavy chain with one N-glycosylation site

Several O-glycosylation sites

16
Q

What are Potential Problems with Biosimilars?

A

Altered biological activity

Changed pharmacokinetics

Altered stability

There is currently no system in place to determine formation of ADA prevalence (unregulated/unlimited switching from originator to biosimilar product) – can’t identify pattern of events

17
Q

Brand substitution by pharmacists without reference to the prescriber is permitted for PBS prescriptions where?

A

The patient agrees to the substitution

The brands are identified as being interchangeable

The prescriber has not indicated on the prescription form that substitution is not to occur

Substitution is permitted under the relevant State or Territory legislation