What’s in a name - biosimilars?
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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
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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?
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Biosimilar ≠ generic
What’s in a name – biosimilars?
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1.Size
What’s in a name – biosimilars?
Asprin vs IgGFrom: Kozlowski et al NEJM 2011;365:385-388
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1. Size
2. Complexity – 4 levels of structure
Biosimilar
What’s in a name – biosimilars?
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1. Size
2. Complexity - glycosylation
What’s in a name – biosimilars?
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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?
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1. Size
2. Complexity
3. Variability
Biosimilar ≠ generic
Comparable ≠ bioequivalent
What’s in a name – biosimilars?
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Naming safety • Information• Warning• Clarity
What’s in a name – biosimilars?
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Naming safety For biosimilars:• Identify reference product• Distinguish from other biosimilars• Clarify use
What’s in a name – biosimilars?
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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?
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Thank you!
What’s in a name – biosimilars?