professor aws alshamsan, bpharm, rph, phd, saudi...
TRANSCRIPT
![Page 1: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/1.jpg)
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
![Page 2: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/2.jpg)
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
![Page 3: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/3.jpg)
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
![Page 4: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/4.jpg)
BIOSIMILARS
Dr. Alshamsan 4
Biological medicinal product that is highly similar to anotherbiological medicine that has already been approved for use
![Page 5: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/5.jpg)
Biosimilarity
Manufacturing Process
Quality Attributes
Clinical Outcome
![Page 6: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/6.jpg)
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
![Page 7: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/7.jpg)
7
BIOSIMILARS
Dr. Alshamsan
![Page 8: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/8.jpg)
8
Reference Product
Dr. Alshamsan
![Page 9: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/9.jpg)
9
BIOSIMILARS
Dr. Alshamsan
![Page 10: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/10.jpg)
Totality of the
Evidence
manufacturing experience
clinical knowledge
PK/PD information
structural complexity evaluation
quality attributes
immunogenicity
![Page 11: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/11.jpg)
11
BIOSIMILARS SUBMISSION GUIDE
Complete Drug Application
Biosimilars Samples
Application Form
Product Dossier eCTD
Format
Dr. Alshamsan
![Page 12: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/12.jpg)
12
Department-Centric Evaluation
ApprovalQuality Assessment
Safety and Efficacy
Assessment
Sample Testing
Inspection
Pricing
Post-Marketing
Surveillance
290 days
Dr. Alshamsan
![Page 13: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/13.jpg)
13
![Page 14: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/14.jpg)
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
![Page 15: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/15.jpg)
Examples of Rejected Products
• Follitropin alfa: Failure in Clinical comparability
• 6 Insulins: Failures in quality, safety, and efficacy
15
![Page 16: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/16.jpg)
16
Product-Centric Evaluation
<<<290 days
Dr. Alshamsan
![Page 17: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/17.jpg)
17
INTERCHANGEABILITY
Dr. Alshamsan
INTERCHANGEABILITY
SWITCHING
SUBSTITUTION
![Page 18: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/18.jpg)
18
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
![Page 19: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/19.jpg)
19
BacteriaYeast
PlantInsect
AnimalHuman
COMPLEXITY
Dr. Alshamsan
![Page 20: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/20.jpg)
Dr. Alshamsan
20
AGGREGATION
Section 3.2.S.3
Characterization of Impurities
Dr. Alshamsan
![Page 21: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/21.jpg)
21
Biosimilars in rheumatology: current perspectives and lessons learnt.
Thomas Dörner, Jonathan Kay
Nat Rev Rheumatol. 2015 Dec; 11(12): 713–724
Dr. Alshamsan
![Page 22: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/22.jpg)
(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-
![Page 23: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/23.jpg)
23
LEVELS
Interchangeability
Switching
Substitution
• Regulator
• Local authority
• Prescriber
• Patient
• Local authority
• Pharmacist
Dr. Alshamsan
![Page 24: Professor Aws Alshamsan, BPharm, RPh, PhD, Saudi Arabiagabi-journal.net/wp-content/uploads/Alshamsan-V18J26LB.pdf · Biosimilars Regulatory Considerations in Saudi Arabia Aws Alshamsan,](https://reader030.vdocuments.site/reader030/viewer/2022013019/5e0bad7225bb1906be209092/html5/thumbnails/24.jpg)
Dr. Alshamsan
Biosimilar Celebrities
24Dr. Alshamsan