A training session organized by Centre for Quality Sciences on Biosimilar Products at Hotel Marriott, Karachi - 29 May 2022

2. Applied Regulatory Science of
Biosimilar Products
Obaid Ali
BSc., BPharm., MPhil, Ph.D.
Advisor Life Sciences – CQS

3. Centre for Quality Sciences
WWW.ORCQS.COM
With
Dr. Obaid Ali
BSc, BPharm, MPhil, PhD
Alumni International Forum of Regulators,
CDER, US-FDA & HPFB, Health Canada,
Former Senior Officer DRAP
Learning Objectives for Professionals of
Pharmaceutical, Biological, Medical, Health, Chemical Sciences:
• What are the Basics and Essentials of Biosimilar?
• What is the Promise and Claim of Biosimilar?
• What are the Critical Quality Attributes of Biosimilar?
• What is Analytical Data for Biosimilar?
• How Biosimilars are developed?
• What is the approval process of Biosimilar?
• When a Biosimilar is substituted?
• Why every Biosimilar cannot be substituted?
• What is the concept of Interchangeability?
• What is Immunogenicity profile in Biosimilar?
CQS’s Certificate Course on
Applied Regulatory Science of
Biosimilar Products

4. What are the Basics
and Essentials of
Biosimilar?
Safe and effective treatment option, reduced
cost, monopoly threats and increased
accessibility

5. What is the Promise
and Claim of
Biosimilar?
Similar therapeutic effect at low cost and
developed under the highest level of scientific
inputs ending up on verifiable totality of
evidences.

6. What are the
Critical Quality
Attributes of
Biosimilar?
Features that can impact safety, potency,
pharmacokinetics and overall quality.
Post-transitional modification to a protein may
not be excluded.

7. What are the Post-
Transitional
Modification of
Biosimilar?
Example:
Addition of oligomannose glycans which
impacts PK properties and reduce clearance
time.
Alter immunogenicity of protein impacting
patient safety and product efficacy.

8. What are the
Critical Quality
Attributes of
Biosimilar?
Structural and functional characteristics that
can impact on quality and performance of the
product.

9. What are the
Critical Quality
Attributes of
Biosimilar?
Selection of CQAs depends upon reference
product and its known mechanism of action.
Molecular structure, purity and bioactivity are
under microscope.

10. What are the
Critical Quality
Attributes of
Biosimilar?
Biological activity, PK, PD, immunogenic effect,
efficacy, safety are prime subjects when risk and
degree of uncertainty is calculated.

11. What are the
Critical Quality
Attributes of
Biosimilar?
Physiochemical studies to evaluate primary
structure, higher order structure and impurities.
Functional studies to evaluate attributes such as
target binding and target neutralization.

12. What is Analytical
Data for Biosimilar?
Essential factors for comparative analytical
assessment include expression system,
manufacturing process, physiochemical
properties, functional activities, target binding,
impurities, reference product and reference
standard, finished drug product and its stability.

13. What is Analytical
Data for Biosimilar?
Reference, proposed product, accounting for
reference & proposed product lots.
Risk, quantitative & qualitative data analysis.
Comparative analytical assessment to conclude

14. How Biosimilars are
developed?
Comparison between reference product &
candidate product
Consideration of previous findings of reference
product is critical

15. How Biosimilars are
developed?
There is a difference between determination of
Biosimilarity and determination of safety and
effectiveness.

16. How Biosimilars are
developed?
Pursuance to development of Biosimilar,
identification of areas of development that
don’t need to be repeated is the key.
Analytical data is the foundation of Biosimilar
development

17. How Biosimilars are
developed?
Similar or highly similar, identify potential
differences between reference and candidate
product that can impact on clinical
performance

18. How Biosimilars are
developed?
Meaningful or no meaningful clinical
differences. PK and PD data, clinical
immunogenicity assessment that looks for
incidence & severity responses.
Remaining residual uncertainty are assessed by
additional studies

19. How Biosimilars are
developed?
Highly similar and support of totality of
evidence navigates Biosimilarity

20. How Biosimilars are
developed?
Clinical studies are not extrapolated for
different indications.
Similarity justification and previous
information are used to extrapolate
Biosimilarity

21. What is the
Approval Process of
Biosimilars?
Rigorous process of review foe safety,
effectiveness and quality.
Biosimilarity, not the expensive clinical trials for
safety and efficacy.
Highly similar with no clinically meaningful
differences.

22. What is the
Approval Process of
Biosimilars?
Analytical studies (structural & functional)
Animal studies to assess comparative toxicity &
safety profile
Comparative clinical pharmacology studies
include PK (Time–Concentration), PD (Time–
Response) and PK&PD (Concentration–
Response)

23. What is the
Approval Process of
Biosimilars?
Additional studies for safety & efficacy,
immunogenicity
Based on evidences …. That are supposed to be
verifiable and carry reason to trust

24. When a Biosimilar
is substituted?
When option is available, it is certainly a matter
of practice, not the science. Pharmacy and
medicines are practiced under the respective
regulations of provinces.
Substitute does not mean interchangeability in
this case of Biosimilar product.

25. Why every
Biosimilar cannot
be substituted?
It can be substituted, however, clinical
judgment and real time evidences of real world
are respected to explore the reason either.

26. What is the concept
of Inter-
changeability?
When a substitution during the treatment
period is proven to maintain clinical meaning
unchanged with all variabilities.

27. What is
Immunogenicity
profile in
Biosimilar?
It is established case by case.
Characterization of potential differences b/w
the Biosimilar Test & Reference Product in
terms of incidence and severity of human
responses.

28. Centre for Quality Sciences
WWW.ORCQS.COM
With
Dr. Obaid Ali
BSc, BPharm, MPhil, PhD
Alumni International Forum of Regulators,
CDER, US-FDA & HPFB, Health Canada,
Former Senior Officer DRAP
Learning Objectives for Hospital /Clinical Pharmacists:
• Why it is called similar, why not equal?
• When it can be substituted by Pharmacist?
• When and why it cannot be substituted by Pharmacist?
• Why one should be concerned on Interchangeability?
• How a Biosimilar product is developed?
• How a Biosimilar product is evaluated?
• How a Biosimilar product is approved?
• How totality of evidence is calculated?
• How chemistry is critical for the functionality?
• How the formulation is critical for its stability?
CQS’s Certificate Course on
Applied Regulatory Science of
Biosimilar Products