Subsequent Entry BiologicsPatient Perspective

Gail Attara, Chief Executive Officer

Gastrointestinal Society

Chair, Best Medicines Coalition

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…

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

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

monoclonal antibody

aspirin

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.

monoclonal antibody

aspirin

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.

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

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

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

Patient Engagement

we strongly support an

environment of patient

engagement in all stages of the

medication continuum for patient

safety

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