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Different Biological Product and
Difference Between Generic and Biosimilar
1
Guided by:
Dr. Hiral Dave
Associate Professor
Prof. of Department of
QA,RA,PA
Prepared By :
Charmi Shah
2308212170009
Parul Institute of Pharmacy
Parul University, Limda
Contents
2
Overview of biological product
Different biological products
Source of biological product
Biological product to the US market
Challenges for Biological Products
Difference Between Generic and Biosimilar
References
What is a Biological product?
• Biological products, or biologics are medical products.
• Biological products could be made of sugars, proteins or nucleic
acids or complex combinations of these substances, or may be living
entities such as cells and tissues.
• Like drugs, biological products are used to either:
Treat or cure diseases and medical conditions
Prevent disease
Diagnose diseases
• Biological products are made from a variety of natural sources.
3
Overview of biological product:
Definition of biological products:
The term biological product means virus, therapeutic serum, toxin, anti
toxin, vaccine, blood, blood component or derivative , allergenic product,
protein, or analogous product or arsphenamine or derivative of
arsphenamine, applicable to the prevention, treatment or cure of a disease
or condition of human beings.
Examples : Biological products are used for a wide range of disease and
conditions, including serious and life threatening conditions such as
cancers and rheumatoid arthritis. Some example of biological products
and their uses:
4
 Botox: has both dermatologic and neurologic uses
 Herceptin : for a certain type of breast cancer
 Vaccines: the shingles vaccine and the flu vaccines
 Enbrel: for rheumatoid arthritis and psoriasis
5
Source of biological product
6
Types/different biological products
7
Biological product to the US market
A manufacturer who seeks to market a biological product must submit a biologics license
application (BLA), which includes:
 Manufacturing information to demonstrate the company can properly and consistently
manufacture the biological product
 Data and information regarding the biological product (e.g., studies in animals and
humans)
The biological product is licensed and can be marketed in the United States only if
 FDA determines that the data shows the biological product is safe and effective for its
proposed use, and
 The biological product can be manufactured in a way that ensures a quality product.
8
Challenges for Biological Products
 Must be processed under tightly controlled conditions/controls throughout
production to:
o Consistently produce a safe, pure, and potent product, and
o Preclude the introduction of environmental contamination
 Biological products may be susceptible to extreme temperatures and light:
o Typically need refrigeration but may need frozen storage or preservatives.
o Shelf life may be limited.
9
Generic drug:
 A new small molecule drug needs to go through years of testing in clinical trials. If it’s
shown to be safe and effective, a New Drug Application must be submitted and
approved before it can be marketed. This is how brand-name medications become
available.
 Generic drugs go through a shorter version of this process — called an Abbreviated
New Drug Application. The FDA’s Office of Generic Drugs is responsible for
reviewing and approving new generic drugs.
 Since generics are copies of a brand-name drug, they get to skip several steps of the
typical approval process. Instead of proving that they’re safe and effective, generics
need to meet several criteria to show they are equivalent to the brand version,
including:
10
Continue….
• Same dosage form, strength, and route of administration
• Same intended use(s)
• Same quality
• Maintains its potency and purity for a reasonable amount of time
• Absorbed into the bloodstream at the same rate
 Generic works the same as the brand-name version. It also needs to meet the same
quality and safety standards. So, you should expect the same benefits and risks in
most cases.
11
Biosimilars
 Biosimilars are more complex and come from living sources.
 Biosimilars are a type of biologic medication that is safe and effective for the
treatment of many chronic and severe conditions, including:
1. Chronic skin diseases (such as psoriasis)
2. Chronic bowel diseases (such as colitis, Crohn’s disease, and irritable bowel
disorder)
3. Diabetes
4. Multiple Sclerosis
5. Kidney conditions
12
Continue…..
 Biologics are approved through a different regulatory process. This is called a
Biologics Licensing Application. Biologics still need to go through clinical trials
to show they’re safe and effective. But there’s additional focus on how they’re
made since there may be some variability.
 Like generics, biosimilars go through an abbreviated version of this process. The
FDA’s Center for Biologics Evaluation and Research (CBER) usually reviews
and approves new biologics (and biosimilars).
13
Difference Between Generic and Biosimilar
Characteristics Generic Biosimilar
Molecular source Inorganic material Living organisms
Molecular size Small and simple Large and complex
Molecular structure Known and well characterized May not be completely
defined of known
Immunogenicity Typically not immunogenicity Usually immunogenic
Route of administration Typically oral Usually injectable
14
Difference Between Generic and Biosimilar
Characteristics Generic Biosimilar
Time to market 2-3 years 7-8 year
Synthesis Structure chemically synthesized
to be identical to reference
structure
Compound is produced by cell lines
that are similar to but will never be
identical to the reference drug
structure
FDA resources Orange book( provides
information on bioequivalence
and therapeutic equivalence of
generic and brand medication)
Purple book(provides information on
bio similarity and interchangeability
of biosimilar and the reference
biologic)
15
Difference Between Generic and Biosimilar
16
Characteristics Generic Biosimilar
Manufacturing Produced by using chemical
synthesis.
Less sensitive to production
process changes
Produced by biological process in host
cell line
Sensitive to production process
changes - expensive and specialized
production facilities
Clinical development Reproducibility easy to
established often only phase
1 studies
Reproducibility difficult to establish
Extensive clinical studies, including
Phase I-III
Difference Between Generic and Biosimilar
Characteristics Generic Biosimilar
Adverse immune
reaction
Lower potential and predictable Higher potential and
unpredictable
Composition Active ingredient that are
identical to the innovator product
Active proteins or peptides that
is not identical
Approval
requirement
Small clinical trials mostly in
healthy volunteers
Phase 3 onwards extensive
clinical trials in patients
17
References
1. Caseyl3. Pharmacist’s Corner: Biosimilars And Generic Drugs Veterinary
Medicine At Illinois. Available From:
https://vetmed.illinois.edu/2023/05/12/pharmacists-corner-biosimilars-and-
generic-drugs/
2. Biological Product Definitions What Is A Biological Product Available From:
https://www.fda.gov/files/drugs/published/biological-product-definitions.pdf
3. Omudhome Ogbru, Pharm d. Biologics (Biologic Drug Class) Medicine Net.
Medicine Net; 2019. Available From:
https://www.medicinenet.com/biologics_biologic_drug_class/article.htm
18
19

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different biological product and difference between biosimilllar and generic

  • 1. Different Biological Product and Difference Between Generic and Biosimilar 1 Guided by: Dr. Hiral Dave Associate Professor Prof. of Department of QA,RA,PA Prepared By : Charmi Shah 2308212170009 Parul Institute of Pharmacy Parul University, Limda
  • 2. Contents 2 Overview of biological product Different biological products Source of biological product Biological product to the US market Challenges for Biological Products Difference Between Generic and Biosimilar References
  • 3. What is a Biological product? • Biological products, or biologics are medical products. • Biological products could be made of sugars, proteins or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. • Like drugs, biological products are used to either: Treat or cure diseases and medical conditions Prevent disease Diagnose diseases • Biological products are made from a variety of natural sources. 3
  • 4. Overview of biological product: Definition of biological products: The term biological product means virus, therapeutic serum, toxin, anti toxin, vaccine, blood, blood component or derivative , allergenic product, protein, or analogous product or arsphenamine or derivative of arsphenamine, applicable to the prevention, treatment or cure of a disease or condition of human beings. Examples : Biological products are used for a wide range of disease and conditions, including serious and life threatening conditions such as cancers and rheumatoid arthritis. Some example of biological products and their uses: 4
  • 5.  Botox: has both dermatologic and neurologic uses  Herceptin : for a certain type of breast cancer  Vaccines: the shingles vaccine and the flu vaccines  Enbrel: for rheumatoid arthritis and psoriasis 5
  • 8. Biological product to the US market A manufacturer who seeks to market a biological product must submit a biologics license application (BLA), which includes:  Manufacturing information to demonstrate the company can properly and consistently manufacture the biological product  Data and information regarding the biological product (e.g., studies in animals and humans) The biological product is licensed and can be marketed in the United States only if  FDA determines that the data shows the biological product is safe and effective for its proposed use, and  The biological product can be manufactured in a way that ensures a quality product. 8
  • 9. Challenges for Biological Products  Must be processed under tightly controlled conditions/controls throughout production to: o Consistently produce a safe, pure, and potent product, and o Preclude the introduction of environmental contamination  Biological products may be susceptible to extreme temperatures and light: o Typically need refrigeration but may need frozen storage or preservatives. o Shelf life may be limited. 9
  • 10. Generic drug:  A new small molecule drug needs to go through years of testing in clinical trials. If it’s shown to be safe and effective, a New Drug Application must be submitted and approved before it can be marketed. This is how brand-name medications become available.  Generic drugs go through a shorter version of this process — called an Abbreviated New Drug Application. The FDA’s Office of Generic Drugs is responsible for reviewing and approving new generic drugs.  Since generics are copies of a brand-name drug, they get to skip several steps of the typical approval process. Instead of proving that they’re safe and effective, generics need to meet several criteria to show they are equivalent to the brand version, including: 10
  • 11. Continue…. • Same dosage form, strength, and route of administration • Same intended use(s) • Same quality • Maintains its potency and purity for a reasonable amount of time • Absorbed into the bloodstream at the same rate  Generic works the same as the brand-name version. It also needs to meet the same quality and safety standards. So, you should expect the same benefits and risks in most cases. 11
  • 12. Biosimilars  Biosimilars are more complex and come from living sources.  Biosimilars are a type of biologic medication that is safe and effective for the treatment of many chronic and severe conditions, including: 1. Chronic skin diseases (such as psoriasis) 2. Chronic bowel diseases (such as colitis, Crohn’s disease, and irritable bowel disorder) 3. Diabetes 4. Multiple Sclerosis 5. Kidney conditions 12
  • 13. Continue…..  Biologics are approved through a different regulatory process. This is called a Biologics Licensing Application. Biologics still need to go through clinical trials to show they’re safe and effective. But there’s additional focus on how they’re made since there may be some variability.  Like generics, biosimilars go through an abbreviated version of this process. The FDA’s Center for Biologics Evaluation and Research (CBER) usually reviews and approves new biologics (and biosimilars). 13
  • 14. Difference Between Generic and Biosimilar Characteristics Generic Biosimilar Molecular source Inorganic material Living organisms Molecular size Small and simple Large and complex Molecular structure Known and well characterized May not be completely defined of known Immunogenicity Typically not immunogenicity Usually immunogenic Route of administration Typically oral Usually injectable 14
  • 15. Difference Between Generic and Biosimilar Characteristics Generic Biosimilar Time to market 2-3 years 7-8 year Synthesis Structure chemically synthesized to be identical to reference structure Compound is produced by cell lines that are similar to but will never be identical to the reference drug structure FDA resources Orange book( provides information on bioequivalence and therapeutic equivalence of generic and brand medication) Purple book(provides information on bio similarity and interchangeability of biosimilar and the reference biologic) 15
  • 16. Difference Between Generic and Biosimilar 16 Characteristics Generic Biosimilar Manufacturing Produced by using chemical synthesis. Less sensitive to production process changes Produced by biological process in host cell line Sensitive to production process changes - expensive and specialized production facilities Clinical development Reproducibility easy to established often only phase 1 studies Reproducibility difficult to establish Extensive clinical studies, including Phase I-III
  • 17. Difference Between Generic and Biosimilar Characteristics Generic Biosimilar Adverse immune reaction Lower potential and predictable Higher potential and unpredictable Composition Active ingredient that are identical to the innovator product Active proteins or peptides that is not identical Approval requirement Small clinical trials mostly in healthy volunteers Phase 3 onwards extensive clinical trials in patients 17
  • 18. References 1. Caseyl3. Pharmacist’s Corner: Biosimilars And Generic Drugs Veterinary Medicine At Illinois. Available From: https://vetmed.illinois.edu/2023/05/12/pharmacists-corner-biosimilars-and- generic-drugs/ 2. Biological Product Definitions What Is A Biological Product Available From: https://www.fda.gov/files/drugs/published/biological-product-definitions.pdf 3. Omudhome Ogbru, Pharm d. Biologics (Biologic Drug Class) Medicine Net. Medicine Net; 2019. Available From: https://www.medicinenet.com/biologics_biologic_drug_class/article.htm 18
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