Bio-Similars

What we know
PUNDALIK PAI
What is a Biological product
1. large, complex molecules
used for medical purpose.
2. Used to diagnose, prevent,
treat, and cure diseases and
medical conditions.
3. Produced through
biotechnology in a living
system, such as a
microorganism, plant cell, or
animal cell.
4. Difficult to characterize
5. E.g. monoclonal antibodies,
enzymes, proteins etc.
6. Insulin is first biological
medicine to be produced
commercially, followed by
various antibiotics.
How biological medicines are manufactured
commercially?

Recombinant DNA technology

Biosimilar / Similar biological medicinal
product
As per USFDA, its Follow-on biologics
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from
an existing FDA-approved reference product.
As defined by EMA,
A biological medicinal product that contains a version of the active substance from already authorized original
medicinal product (reference product) with similarity established in terms of
1. quality
2. Biological activity
3. safety
4. efficacy
Based upon a comprehensive comparability exercise.
Biosimilar- Similar but not same
Even though minor differences are acceptable biosimilars
should not differ in clinical terms.
Who are not Biosimilars?
1. Intended copies
2. Biobetters
3. Standalone products

Are biosimilars interchangable -Switching

Heterogeneity
Types
1. Micro
2. Macro

Because of Longitudinal variation

Hence Comparability exercise

Regulatory pathway for biosimilars
Controversy

1. Nomenclature

2. Immunogenicity
Questions?
1. Where can you find more information about biosimilar and interchangeable products?
Purple book

2. Can a biosimilar be approved for an indication that is approved for the reference product
even if the biosimilar is not directly studied in that indication?
Concept of extrapolation

3. Biosimilar approval process comes under which act?

BPCI act 2009 (Biologics price competition and innovation act)
Thanks