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Printable Handouts
Navigable Slide Index
- Introduction
- Biosimilars
- Overview (1)
- Biological / biotech medicines (1)
- Biological / biotech medicines (2)
- Biological / biotech medicines (3)
- Biological medicine complexity
- Variability in original Adalimumab
- Safety and efficacy in non-identical batches
- The lock and key model
- Overview (2)
- Etanercept: clinically acceptable differences
- Comparison analysis
- Biosimilar development
- Bioequivalence
- Safety and efficacy (1)
- Safety and efficacy (2)
- Stringent regulatory standard
- Sub-standard products
- A Biosimilar is not a NCB (1)
- A Biosimilar is not a NCB (2)
- Withdrawal of biosimilar candidates
- Overview (3)
- Switch experience among original biologics
- “Non-medical” switch among original ESA
- Original Adalimumab case (1)
- Original Adalimumab case (2)
- Biosimilar extrapolation
- Massive switch
- Original to biosimilar switch: Europe expierence
- British Society of Gastroenterolgy: Infliximab switch recommended
- Biosimilarity is interchangability
- Overview (4)
- Focusing on the patient
- Biosimilars added value
- Arrival of biosimilars: added value
- Impact of biosimilars on access to biologics
- Access to clinical trials
- Biosimilars and innovation
- The value of switching
- Empirical confirmation
- Conclusion
- Thank you
Topics Covered
- Biologic versus Non-biologic medicines
- Biosimilars development: milestones
- Original-to-biosimilar interchangeability
- Impact of biosimilars on access to biologics
- A value proposition for biosimilars
Links
Categories:
External Links
- Slide 14 - guideline on similar biological medicinal products
- Slide 18 - List of stringent regulatory agencies (SRA's)
- Slide 19 - Substandard and falsified medical products
- Slide 22 - Rituximab Mabion: Withdrawal of the marketing authorisation application
- Slide 26 - Summary review for regulatory action
- Slide 31 - Celltrion Healthcare on Remsima and biosimilars
- Slide 37 - The Impact of Biosimilar Competition in Europe
- Slide 41 - Biosimilars in the EU
Talk Citation
de Mora, F. (2023, March 30). Biosimilars: when value meets cost [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 26, 2024, from https://doi.org/10.69645/QFJT3683.Export Citation (RIS)
Publication History
Financial Disclosures
- Prof. Fernando de Mora has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
A selection of talks on Clinical Practice
Transcript
Please wait while the transcript is being prepared...
0:00
Hello, I am Fernando de Mora
Professor of Pharmacology at
a fairly big Spanish
University called
Universidad Autónoma de
Barcelona, a public University.
I have been asked to
deliver a talk on
biosimilars and try to
convey the message that volume
meets costs in that case.
0:20
So the message that I want to
deliver would be biosimilar,
in fact, is a
biological medicine.
that shares the active substance
with an original biologic.
It is administered
by the same route,
at the same dose, and for
the same indications.
What I want to do
is I want to try to
help you understand why
can we conclude this?
0:43
We will address this issue
by discussing four topics.
I will start with
explaining what is
a biologic medicine vs
non-biological medicine.
0:54
Well, let's assume
for the purpose of
this talk that a biologic
is just a medicine,
obtained from a living organism.
If we go to legal definitions,
that is far more complicated.
But we can consider
that whenever
a living organism is
producing the medicine,
it is a biologic medicine.
For instance, insulin
from the pancreas.
That was at that time
a biologic medicines.
But we can also obtain
biologic medicines
from human sources.
For instance, factor VIII.
If I get the blood,
extract blood from
healthy volunteers,
I can isolate the
coagulation factor VIII
and use it in
hemophilic patients.
Now, is there an
alternative source of
this human factor
VIII? Indeed there is.