Generic biologics (Biosimilar drug products)

1. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 1
RAJARSHI SHAHU COLLEGE OF
PHARMACY , BULDANA
 Advanced Biopharmaceutics & Pharmacokinetics
 Topic : GENERIC BIOLOGICS
( BIOSIMILAR DRUG PRODUCTS )
 M . Pharmacy 1st Year 2nd Semester
 Department Of Pharmaceutics
 Presented By : Jaypal Rajput
 Under The Guidance Of : Dr . Vijay Sonar

2. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 2
Contents
 Introduction
 History
 Requirements
 Difference Biologic And Biosimilars
 Difference Biosimilars And Generic
 Biosimilar Industries Around The World
 Biosimilar Industries In India
 Approval
 Safety
 Conclusion

3. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 3
Introduction
 Generic
A generic drug is a pharmaceutical drug that contains the same
chemical substance as drug that was originally protected by
chemical patents
 Biologics
A therapeutic agent manufactured in a living system such as a
microorganism , plant or animal cell using recombinant DNA
technology

4. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 4
 Biological products
• Biological products are a diverse category of products and are
generally large, complex molecules.
• These products may be produced through biotechnology in a living
system, such as a microorganism, plant cell, or animal cell
• And that are often more difficult to characterize than small
molecules drugs

5. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 5
Vaccine Blood Blood Components
Cell Gene Tissue

6. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 6
 Biosimilar
A biosimilar drug that is very much like another biological
drug (called the reference drug) that has already been approved by
the U.S. Food and Drug Administration (FDA) and has no clinically
meaningful differences in terms of safety and effectiveness from the
reference product
A biosimilar drug is a safe and effective, high-quality treatment that
is "highly similar with no meaningful clinical differences" to a brand
name biologic drug that's used to treat a certain disease.

7. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 7
• Almost identical copy of an original biological product
• They are large molecules with complex structures
• They are prepared from engineered organisms
• e.g.: Insulin produced from E-Coli

8. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 8
 According WHO
• The term is Similar Biologic Product
• Similar to an already licensed reference bio therapeutic product in
terms of quality, safety & efficacy
 According US-FDA
• The term is Follow-on Biologic
• Highly similar to reference biologic product without clinically
meaningful differences in safety, purity and potency

9. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 9
 History
• In late 1960's, the FDA developed the Abbreviated New
Drug Application (ANDA) for approval of generic drug
• The 1st ever "similar biologic product manufactured by India was a
Hep-B vaccine named BIOVAC B in 2000
• The 1st biosimilar approved by EMEA (Europe, Middle East,
Africa) was OMNITROPE which is a biosimilar Recombinant
Human Growth Hormone in Year 2006
• US-FDA manufactured 1st follow up biologic Zarxio (Filgrastim)
in 2015

10. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 10
 Biosimilars Include
• Blood and Plasma products
• Non recombinant products
• Recombinant products
• Monoclonal antibodies
• Vaccines

11. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 11
 Requirements for Biosimilars
• It should be biologic product
• Reference product should be an already licensed biologic product
• The biosimilar should demonstrate a high similarity of safety,
quality and efficacy to that of the reference product
• Similarity should be determined by comparing the biosimilar
product with the reference product based on quality, non clinical
and clinical studies

12. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 12
 Differenece between biologic and biosimilars
• Biologic drugs are large, complex proteins made from living cells
through highly complex manufacturing processes.
• Unlike generic drugs, which are copies of chemical drugs
• A biosimilar is a copy of a biologic medicine that is similar, but not
identical, to the original medicine
• It enters the market subsequent to a previously authorized version
whose patent has expired and is approved only after showing that it is
“highly similar” to an approved biological product

13. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 13

14. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 14
• Compared to a biologic, it can be easier to get a Biosimilar
approved by regulatory agencies
• Because the structural difference between biologics and biosimilars
is so minimal, it becomes very easy to make the mistake of assuming
they are identical. However, this does not make them interchangeable
• Biosimilars are often given the same indications as the originator
drugs in order to reduce the development cost, hence the market
price, making it more accessible and affordable to patients

15. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 15
 Difference between biosimilars and generic drug
• Biosimilar drugs and generic drugs are two different things
• Generic drugs contain identical medicinal ingredients to their
reference products. They are composed of small molecules that are
chemically synthesized.
• Biosimilar drugs and their reference biologics are very similar but
not identical.

16. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 16
• Source
living organism (Biosimilars)
chemical synthesis (Generic)
• Size
Large molecule (Biosimilars)
small molecule (Generic)
• Structure
Complex, heterogeneous (Biosimilars)
well defined (Generic)

17. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 17
• Manufacturing process
Difficult (Biosimilars)
Relative simple (Generic)
• Stability
Unstable, sensitive to external conditions (Biosimilars)
Stable (Generic)
• Immunogenicity
Immunogenic (Biosimilars)
Mostly non immunogenic (Generic)

18. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 18
• Interchangeable with reference product
No (Biosimilars)
Yes (Generic)
• Cost
High (Biosimilars)
Low (Generic)

19. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 19
 Biosimilar Industries Around The World

20. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 20
 Biosimilar Industries In India
• Biosimilars approved and used in India mainly consist of
the vaccines, monoclonal antibodies, insulin, and recombinant
proteins
• India has achieved the distinction of being the second largest
supplier of vaccines in the world
1. Cipla
2. Lupin
3. Biocon ltd
4. Cadila Healthcare (Zydus) 5. Dr. Reddy's laboratories

21. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 21
 Who approves biosimilars in India?
• The regulations stem from biosimilar guidelines originally Drafted
in 2012 by 2 Indian governmental agencies, the Central Drugs
Standard Control Organization (CDSCO) and the Department Of
Biotechnology (DBT), meant to address and improve the
development and approval process for biosimilars
• India has over 95 approved biosimilars in the domestic market more
than any other country and market penetration
• Biosimilars emerging as one of the fastest-growing sectors in the
market
• Rules regarding clinical trials are much more stringent for
biosimilars than those applied to generics

22. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 22
Biosimilars are also regulated for various processes
(e.g, clinical trials, import and manufacture) and are governed
primarily by:
• Drugs and Cosmetics Act (1940; and Rules 1945);
• New Drugs and Clinical Trial Rules (2019);
• Guidelines on Similar Biologics;
• Regulatory Requirements for Marketing Authorisation in India
(2016);
• Rules for Manufacture, Use, Import, Export and Storage of
Hazardous Microorganisms and Genetically Engineered Organisms
or Cells (1989);

23. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 23
• Environment (Protection) Act (1986);
• Regulations and Guidelines on Biosafety of Recombinant DNA
Research and Biocontainment (2017);
• CDSCO Guidance for the Industry (2008);
• Guidelines for Generating Pre-clinical and Clinical Data for rDNA
Vaccines, Diagnostics and other Biologicals (1999);

24. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 24
 Some Biosimilars Approved In India
(Rheumatoid arthritis)

25. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 25
Are biosimilar drugs safe?
• There are strict rules about how a biosimilar drug is tested
for its Safety
• Just like any drug, a biosimilar drug is tested in clinical trials to make
sure it is safe to use in people
• The data from the clinical trials are carefully reviewed by the (FDA)
to be sure the biosimilar drug is just as safe and effective as its brand
name biologic drug this means it has met the strict standards for
being safe

26. 8/6/2022 GENERIC BIOLOGICS BY JAYPAL RAJPUT 26
 Conclusion
• Biosimilars are not generic versions of originator biologics, but they
are affordable alternatives that work similarly
• For patients who have not begun an original biologic, biosimilars
may be a useful alternative for physicians to prescribe
• However, only qualified health care professionals should be
allowed to switch a patient from an innovator biologic to a
biosimilar, and only if it is best for the patients' health.