BIOSIMILAR.ppt sssssssssssssssssssssssss

biosimilsrs

1. Chhatrapati Shahu Ji Maharaj University
BIOSIMILARS
{CELLULAR MOLECULAR PHARMACOLOGY}

2. CONTENT
INTRODUCTION
DEFINATION
BIOSIMILAR HISTORY
DIFFERENCE B/W BIOSIMILARS & GENERICS
USES OF BIOSIMILARS
POTENTIAL CONCERNS
MANUFACTURING PROCESS

3. INTRODUCTION
BIOLOGICAL DRUGS – essential part of modern
pharmacotherapy
FIRST DEVELOPMENT IN 1980s –
Recombinant technology
Complex proteins (eg. Monoclonal Abs)
(DNA manipulation in bacteria, yeast or mammalian cells)

4. Other eg. – cytokines, hormones,
interleukins, human insulins, clotting
factors, enzymes, vaccines, cell & tissue
based therapies .
Up to 50% share in global
pharmaceutical market in the next few
years .

5. WHAT ARE BIOSIMILARS ?

6. The Synonyms…
Follow – on Biologics (FoBs)
Follow – on protein
Follow – on biologic similar biomedicines
subsequent entry biologicals
SBMP (similar biological medicinal product)
BIOSIMILARS ARE NOT (BIO)GENERICS.

7. Biosimilars includes :
Blood and plasma products
Non recombinant product
Recombinant products
Monoclonal antibodies
Vaccines

8. Biosimilar history :
In late 1960s , the FDA developed the abbreviated
new drug application for approval of generic
drug.
The first ever “similar biologic “ product
manufactured by INDIA was a Hep-B vaccine
named BIOVAC B in 2000.
The first biosimilar approved by EMEA was
OMNITROPE which is a biosimilar Recombinant
Human Growth Hormone In year 2006.
US-FDA manufactured first follow up biologics
Zarixo( Filgastrim) in 2015.

9. Why biosimilars are not
generic drugs?
Generic drugs

Chemical & therapeuti
equivalents of chemical
drugs.
Structure : smaller ,less
complex, 1D
Molecular weight: low
Biosimilar

Copies of existing
biological medicinal
products or protein drugs.
large & complicated
(100-1000x) ,3D
High

10. Generic drugs
More stable
Route: oral
Manufacturing procedure :
less complex
Registration procedure:
simple (ANDA)
Biosimilars
Sensitive to change in
physical conditions.
Injected / Inhaled
Complex , lengthy
&expensive (require
different cell lines)
Complicated (EMEA/
FDA)

11. USES OF BIOSIMILARS
Blood conditions: leuko/ neutro /
pancytopenias
Cancers: Colon & Breast Ca or NHL
Immune system disorders : Rheumatoid
arthritis, Psoriasis & Crohn’s disease
Neurological disorders: Multiple Sclerosis

12. 4 Major concerns :


Safety Substitution Naming Labelling

POTENTIAL CONCERNS

13. MANUFACTURING PROCESS OF
BIOSIMILARS

14. THANK YOU…