Knowledge about biosimilars
Do you know what biosimilars are?
Choose one item that adjusts to your concept of biosmilarsa
A biologic that demonstrates bioequivalence with the original biodrug and has all preclinical and clinical trials equal to those already performed with the original biodrug. Besides, when approved, it already has a well-defined immunogenicity
A biologic that demonstrates bioequivalence with an original biodrug and does not need clinical trials to be commercialized
A molecule equal to that of the original biologic but of lower production cost
An attempt to copy an innovative biodrug and will never be equal to it
A generic biologic of an already commercialized biodrug
Do you agree with the information that there are already marketed biosimilars in the Arab and Middle Eastern Market?
Do you agree with the information that biosimilars are being manufactured in the Arab and Middle Eastern Market?
Do you prescribe biosimilars?
What are the major drivers that encourage you to prescribe biosimilars?
FDA and EMA approval for biosimilar
Good manufacturing practices and high reputation of the manufacturer
Country of origin of the biosimilars’ manufacturer
Lower price of the bioequivalence in comparison with the innovator
Nothing encourages you
What are the major local drivers that encourage you to prescribe biosimilars?
Assurance that phase III clinical trials will be performed in a sample of the local population
Maintenance of an adequate national system of pharmacovigilance specific to biosimilars
Transparency of the local health regulatory authority(ies)
Nothing encourages you
In your opinion, what are the advantages of a biosimilar?
Commercialization approved with initial indication including all diseases previously approved for the innovative biodrug
Administration route different from that of the original biodrug
Lower therapeutic dose
There are no advantages
Now that biosimilars are coming to the market, you think thatd
Patient associations should be informed and should be able to give their opinion
Patients should systematically be given information
We should wait for many patients to receive biosimilars in a real life setting before recommending its use in a large population of patients
We should know in which country the drug has been tested/created before using it in your own country
The biosimilar will be less expensive than the reference drug, you think thatd
These are good news because more patients will be treated with biologics
The cost of a treatment should not come before its effectiveness or safety/tolerance
This will help cost savings
If biosimilars are already in the market, a 30% reduction from the innovator’s price will be sufficient
You do not think that a lower cost will change something
Do you trust a company highly experienced in manufacturing small-molecule generic drugs as a producer of biosimilars knowing that they have the expertise to deal with regulatory authorities and have the knowledge of approval’s guidelines?
Do you trust a company with prior experience in manufacturing biologics as a manufacturer of biosimilars?