Biosimilars are biologic medical products that are almost identical copies of the original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires.

1. Biosimilars:
DEVELOPMENT, APPROVAL
AND THE FUTURE ASPECTS
Presented By:
Sonali Mohapatra
2nd Semester, M.Sc Biotechnologyy
Cental University of Haryana

2. SPOT THE DIFFERENCE:
GENERIC BIOSIMILAR

3. SIMILAR BUT NOT IDENTICAL!
DEFINITION:
● A biosimilar is a biotherapeutic product
which is similar in terms of quality, safety
and efficacy to an already licenced
reference product.
SIMILARITY IN TERMS OF:
● Primary amino acid sequence
● Potency must match the reference
● Same route of administration
● Post-translational modifications
CLINICAL REQUIREMENTS:
● Pharmacokinetics
● Pharmacodynamics
● Efficacy
● Safety
● Immunogenicity

4. DEVELOPMENT OF BIOSIMILARS:

5. Reverse Engineering Process:
Non-clinical Analysis
● Toxicity
● Similarity comparison.
3
Analytical Characterization:
● Structural and functional
comparative analysis
● Protein Characterization
Assays
● RT-PCR
4
Clinical Trial:
● Sufficient exposure
● Detection of relevant safety signals
● Detection of clinically meaningful
differences in effectiveness and safety
1
Clinical Studies:
● Comparative human PK
and PD studies 2

6. Approval Pathway : FDA
Based on:
● Data collected from the prior steps
● Immunogenicity assessment tests
● Monitoring any residual uncertainty
● Extrapolation

7. Future Aspects:
● Robust post-
marketing safety
monitoring
● A better
consumer and
practitioner
education
● Development of
commercial models
● More Competition in
the market

8. REFERENCES:
● https://www.studocu.com/en-gb/document/university-of-strathclyde/evidence-
based-medicine/lecture-notes/notes-biopharmaceuticals-and-
biosimilars/14534000/view
● https://cdn.ymaws.com/www.marylandpharmacist.org/resource/resmgr/2016_Mid
_Year_Meeting/Biosimilars.pdf
● https://www.verzekeringsgeneeskundevlaanderen.be/assets/upload/cache/Opleid
ing/studiedag%2016_10_20/westhovens.pdf
● https://researchadvocacy.org/sites/default/files/resources/Biosimilar%20Medicine
s6_4Final.pdf
● https://drug-dev.com/biosimilar-development-approval-of-biosimilar-medicines-
through-totality-of-the-evidence/
● Slide theme by: https://slidesgo.com

9. THANK YOU