Embed Size (px)
DESCRIPTION
The presentation was given by the TGA at the 2014 ARCS Scientific Congress, and covers the definition of the term 'biosomilars' and its features
Citation preview
Click icon to add picture
What’s in a name – biosimilars?
Kevin Grant
Section Head, Office of Laboratories & Scientific Services,Monitoring & Compliance Group, TGA
ARCS Scientific Congress 2014
10 September 2014
2
What is a biosimilar?A biosimilar is a “copy” version of an approved biological medicine with demonstrated similarity in physicochemical, biological and immunological characteristics, efficacy and safety, based on a comprehensive comparability study.
Biosimilars are variously termed:
• Similar Biotherapeutic Products (WHO)
• Similar Biological Medicinal Products (EU/TGA)
• “biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product” (US FDA)
• follow-on biologics (PMDA, Japan) and
• subsequent entry biologics (Health Canada).
What’s in a name – biosimilars?
3
Biosimilar ≠ generic
What’s in a name – biosimilars?
4
1.Size
What’s in a name – biosimilars?
Asprin vs IgGFrom: Kozlowski et al NEJM 2011;365:385-388
5
1. Size
2. Complexity – 4 levels of structure
Biosimilar
What’s in a name – biosimilars?
6
1. Size
2. Complexity - glycosylation
What’s in a name – biosimilars?
7
Variability – e.g. EPO • Mass = 27948±285 deglycosylated 18240±4
• 2 disulphide bonds• 3 N-glycosylation • 2 O-glycosylation sites• Many types of glycans• C-terminal truncation
Even the most controlled biotechnological process produces a spectrum of 100 000s of molecules – all having different activity, half-life and potential to induce an immune reaction.
What’s in a name – biosimilars?
8
1. Size
2. Complexity
3. Variability
Biosimilar ≠ generic
Comparable ≠ bioequivalent
What’s in a name – biosimilars?
9
Naming safety • Information• Warning• Clarity
What’s in a name – biosimilars?
10
Naming safety For biosimilars:• Identify reference product• Distinguish from other biosimilars• Clarify use
What’s in a name – biosimilars?
11
Naming safety TGA biosimilar naming policy:• ABN of reference product• Biosimilar identifier based on INN• Linked to advice in PI
What’s in a name – biosimilars?
12
Thank you!
What’s in a name – biosimilars?
