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10 October 2018, Le Meridien Dubai, United Arab Emirates
GaBI
Scientific
Meetings
2nd MENA Stakeholder Meeting on Regulatory Approval, Clinical Settings, Interchangeability and Pharmacovigilance of Biosimilars
Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabia
• Professor of Pharmaceutics, King Saud University, Saudi Arabia
• Dean, King Abdullah Institute for Nanotechnology, King Saud University, Saudi Arabia
• Dean (2014–2017), College of Pharmacy, King Saud University, Saudi Arabia
• Consultant, Saudi Food and Drug Authority
10 October 2018, Le Meridien Dubai, United Arab Emirates
GaBI
Scientific
Meetings
2nd MENA Stakeholder Meeting on Regulatory Approval, Clinical Settings, Interchangeability and Pharmacovigilance of Biosimilars
Biosimilars Regulatory Considerationsin Saudi Arabia
Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabia
10 October 2018
Biosimilars Regulatory Considerations in Saudi Arabia
Aws Alshamsan, BPharm, RPh, PhD
Dean and Associate Professor at College of Pharmacy, King Saud University
Consultant of the Drug Sector at SFDA
College of Pharmacy
BIOSIMILARS
Dr. Alshamsan 4
Biological medicinal product that is highly similar to anotherbiological medicine that has already been approved for use
Biosimilarity
Manufacturing Process
Quality Attributes
Clinical Outcome
Associated Risk
controlling critical biomanufacturing
steps
in-process control of
growth and culture
consistency and reproducibility
Long-term stability
Impurity and degradation
profile
immunogenicity
Associated Risk
7
BIOSIMILARS
Dr. Alshamsan
8
Reference Product
Dr. Alshamsan
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BIOSIMILARS
Dr. Alshamsan
Totality of the
Evidence
manufacturing experience
clinical knowledge
PK/PD information
structural complexity evaluation
quality attributes
immunogenicity
11
BIOSIMILARS SUBMISSION GUIDE
Complete Drug Application
Biosimilars Samples
Application Form
Product Dossier eCTD
Format
Dr. Alshamsan
12
Department-Centric Evaluation
ApprovalQuality Assessment
Safety and Efficacy
Assessment
Sample Testing
Inspection
Pricing
Post-Marketing
Surveillance
290 days
Dr. Alshamsan
13
Examples of Approved Products
• Omnitrope: Recombinant Somatropin 2014
• Remsima: Infliximab 2015
• Zarzio: Filgrastim 2015
• Grastofil: Filgrastim 2017
• Binocrit: Erythropoietin 2017
• The biosimilar on average is 37% cheaper
• Biosimilar Uptake
14
Examples of Rejected Products
• Follitropin alfa: Failure in Clinical comparability
• 6 Insulins: Failures in quality, safety, and efficacy
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Product-Centric Evaluation
<<<290 days
Dr. Alshamsan
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INTERCHANGEABILITY
Dr. Alshamsan
INTERCHANGEABILITY
SWITCHING
SUBSTITUTION
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COMPLEXITY
Biosimilars in rheumatology: current perspectives and lessons learnt.
Thomas Dörner, Jonathan Kay
Nat Rev Rheumatol. 2015 Dec; 11(12): 713–724
Host cell type
Process applied
Material used
Separation and purification
Impurities
Stability
Dr. Alshamsan
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BacteriaYeast
PlantInsect
AnimalHuman
COMPLEXITY
Dr. Alshamsan
Dr. Alshamsan
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AGGREGATION
Section 3.2.S.3
Characterization of Impurities
Dr. Alshamsan
21
Biosimilars in rheumatology: current perspectives and lessons learnt.
Thomas Dörner, Jonathan Kay
Nat Rev Rheumatol. 2015 Dec; 11(12): 713–724
Dr. Alshamsan
(1) Changing from an innovator drug to a biosimilar drug which used that sameinnovator drug as its RMP for comparability (or vice versa) can be acceptedafter physician and patient discussion.
(2) Changing from a biosimilar drug to another same biosimilar drug from adifferent manufacturer can be accepted after physician and patient discussiononly if they both used the same RMP for comparability purposes.”
(3) Pharmacists cannot substitute biosimilars without […] consultations withtreating physicians
- Saudi Food and Drug Authority-
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LEVELS
Interchangeability
Switching
Substitution
• Regulator
• Local authority
• Prescriber
• Patient
• Local authority
• Pharmacist
Dr. Alshamsan
Dr. Alshamsan
Biosimilar Celebrities
24Dr. Alshamsan
