c2 - subsequent entry biologics patient perspective - attara - salon e
DESCRIPTION
TRANSCRIPT
![Page 1: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/1.jpg)
Subsequent Entry BiologicsPatient Perspective
Gail Attara, Chief Executive Officer
Gastrointestinal Society
Chair, Best Medicines Coalition
![Page 2: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/2.jpg)
Biologics…
• More than 200 years in Canada
• vaccine for smallpox, 1796
• insulin, 1921
• blood and its components
• human growth hormone
• interferon
• monoclonal antibody technology (mAb)
• many more…
![Page 3: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/3.jpg)
Complexity
• biologic medicines are not new, but…
• they have evolved into
very intricate medicines
that continue to drastically
improve health outcomes
for patients in a number of
serious disease areas
• patients need safety
assurance
![Page 4: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/4.jpg)
Small Molecules
• most common medicines, including dietary
supplements
• created by compounding organic and/or
inorganic chemical substances, which we
typically take orally
• about 90% of medicines are small molecule
![Page 5: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/5.jpg)
monoclonal antibody
aspirin
![Page 6: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/6.jpg)
Large Molecules• structurally elaborate agents
• grown through a complex biologic process
using diverse human, animal, and/or
microorganism (e.g., bacteria, yeast) sources,
and are often produced using recombinant
DNA technology
• more than 1,000 process steps could be
necessary to assemble a complex medicine
and this information is proprietary
• we have to inject or infuse biologics, because
if we take them orally, we’ll digest them.
![Page 7: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/7.jpg)
monoclonal antibody
aspirin
![Page 8: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/8.jpg)
Copying – Not So Easy…
• innovator is not obligated to share its
manufacturing processes
• for small molecule medications, the
processes are relatively simple
• this is not true of biologics, where the
manufacturing process is integral to
creating the medication.
![Page 9: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/9.jpg)
Patient Safety/Naming Issue
• strong regulatory need in Canada for distinguishable international non-proprietary names (INNs) between the innovator and SEB medications to ensure that real world usage data attaches to the applicable medicine
• need to protect physicians’ authority to prescribe the exact biologic or SEB that is right for each patient
![Page 10: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/10.jpg)
Patient Concerns
• large molecule biosimilars/SEBs are
only similar and never bioequivalent
with innovator products
• biologics/SEBs must never have
interchangeability status
• one key can’t open every door
![Page 11: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/11.jpg)
Patient Concerns• SEBs should go through the same
rigorous testing for safety & efficacy as
the innovator for each disease expected
to benefit from the new medicine
• it should not be as easy for SEBs to
expand indications to treat a condition as
it has been for small molecule generic
medications
![Page 12: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/12.jpg)
Patient Engagement
we strongly support an
environment of patient
engagement in all stages of the
medication continuum for patient
safety
![Page 13: C2 - Subsequent Entry Biologics Patient Perspective - Attara - Salon E](https://reader031.vdocuments.mx/reader031/viewer/2022020306/548d1235b47959190d8b64be/html5/thumbnails/13.jpg)
Patient Engagement
patients, as the end users
of these medications, have vital
knowledge about the disease
processes and the potential value
these medications could
add to their lives